(165 days)
Not Found
No
The device description and performance studies focus on mechanical functionality and access, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No
The device is described as an access system for instruments during gynecological procedures and is not intended to treat or cure a disease or condition.
No
The device is a surgical access system designed to facilitate minimally invasive gynecological procedures by providing a pathway for instruments and maintaining insufflation. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components (retractor, access channels, cap, sleeves) and mentions functional bench testing related to these physical components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access for surgical instruments during vaginal gynecological 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 physical system for creating and maintaining surgical access and insufflation. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the device (maintaining access, insufflation, etc.), not on the accuracy or reliability of diagnostic results.
Therefore, the GelPOINT V-Path Vaginal Access System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOK
Device Description
The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
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)
Function Testing:
Functional bench testing was performed to demonstrate the adequate functionality of the Vaginal Access System, as follows:
- Maintenance of transvaginal access
- Facilitation of instrument access to surgical site
- Device removal
- Device retention
- Maintenance of insufflation
The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments and can remain anchored in the patient while withstanding conditions under normal clinical use. The studies also confirm that the integrity and sealing capability of the device system are adequate to maintain insufflation as a means to provide visualization of the surgical space.
Biocompatibility:
Biocompatibility studies were performed in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and "testing" as follows:
- Cytotoxicity: ISO 10993-5:2009
- Sensitization: ISO 10993-10:2010
- Irritation: ISO 10993-10:2010
- Acute Systemic Toxicity: ISO 10993-11:2017
- Pvrogenicity Potential: USP . ISO 10993-11:2017
The biocompatibility test results demonstrate the GelPOINT V-Path Vaginal Access System is biocompatible. The results show the subject device has met the criteria to be classified as a non-cytotoxic, non-sensitizer, non-irritant device that shows no sign of being systemically toxic or pyrogenic.
Shelf-Life:
The GelPOINT V-Path Vaginal Access System has a shelf life of 3 years when packaged in Tyvek and nylon film pouches, in accordance with the results of accelerated aged stability studies. Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration.
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
§ 884.1630 Colposcope.
(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
September 16, 2022
Applied Medical Resources Corporation David Yu Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
Re: K220969
Trade/Device Name: GelPOINT® V-Path Vaginal Access System Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: MOK Dated: August 17, 2022 Received: August 18, 2022
Dear David Yu:
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 statutes and regulations administered by other Federal agencies.
1
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 and Part 809); 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K220969
Device Name GelPOINT® V-Path Vaginal Access System
Indications for Use (Describe)
The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
GelPoint V-Path Vaginal Access System
K220969
| 510(K) Submitter: | Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Yu
Regulatory Affairs Specialist
Applied Medical Resources Corp.
David. Yu@appliedmedical.com
Tel: (949) 713-8023
Fax: (949) 713-8205 |
| Date of Preparation: | September 15, 2022 |
| Trade Name: | GelPOINT® V-Path Vaginal Access System |
| Common Name: | Vaginal endoscopic surgery access port |
| Classification: | Regulation: 884.1630 Colposcope
Device Class: Class II
Product Code: MOK, Vaginoscope and accessories |
| Predicate Device: | Trade Name: KARL STORZ INFANT, BALLOON
VAGINOSCOPE
510(k) #: K950639
Product Code: MOK |
| | Through FDA database search following predicate device has
been identified: KARL STORZ INFANT BALLOON
VAGINOSCOPE manufactured by KARL STORZ
ENDOSCOPY-AMERICA, INC (K950639). No design-related
recalls for these legally marketed predicate devices have
been identified. |
| Indications for use: | The GelPOINT V-Path Vaginal Access System is intended to be
inserted in the vagina to allow for entry of minimally invasive
instruments while maintaining insufflation for vaginal
gynecological procedures. |
4
Device Description
The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.
| Manufacturer | Applied Medical Resources Corp | KARL STORZ
ENDOSCOPY-AMERICA,
INC |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | GelPOINT V-Path Vaginal
Access System
K220969 | KARL STORZ INFANT
BALLOON
VAGINOSCOPE
K950639 |
| General Device
Characteristics | | |
| Device Design | The Vaginal Access System
consists of similarly designed
intravaginal Alexis retractor and a
vaginal access channel
that acts as the anchor for the
intravaginal Alexis retractor.
Intended to be inserted
transvaginally, to allow passage of
minimally invasive instruments for
the purpose of visualizing
gynecological organs, and to allow
for diagnostic and operative
gynecological procedures including
the extraction of specimens | The device consists of a
vaginoscopes, balloon
vaginoscopes, vaginoscope
sheaths, fiber optic light
carrier and adjustable
magnifiers.
Designed to be used for
endoscopic diagnostic and
surgical procedures involving
the infant vagina and cervix. |
| Anatomical Sites | Vagina | Vagina |
| Placement | Transvaginal | Transvaginal |
Comparison of Technological Characteristics with the Predicate Device
5
| Visualization
Capability | Visualization is achieved via
introduction of an endoscope
through an access port. | N/A |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Expansion of
Surgical Space | Utilizes CO2 insufflation via an
insufflator (not included with
device) connected to insufflation
port on the device. | N/A |
| Device
Removals | The intravaginal Alexis retractor
does not include a tether because
the retractor is only placed at the
vaginal introitus and can be
removed after unrolling the outer
ring. The access channel is also
placed at the introitus and is
removed manually by the user. | N/A |
| Materials | Polyether polyurethane,
thermoplastic elastomer | N/A |
| Sterilization | Ethylene Oxide, Sterility
Assurance Level of 10-6
Single use device; device is
discarded after use | N/A |
The subject and predicate device have the same intended use, namely:
- To be inserted vaginally. ●
- To allow passage of minimally invasive instruments for the purpose of . visualizing gynecological organs.
- To allow for diagnostic and operative gynecological procedures including the . extraction of specimens.
The differences in device design, presence of imaging capability, and material do not constitute a new intended use. Additionally, there are no different questions of safety and effectiveness that arise from the differences in technology. The technological differences between GelPOINT V-Path Vaginal Access System and the predicate device can be evaluated through performance testing and do not alter the intended use of the GelPOINT V-Path Vaginal Access System.
Discussion of Performance Data
The subject device and predicate device share the same ability to achieve vaginal access to the vaginal canal. Therefore, bench testing for the subject device was conducted to demonstrate the clinically relevant functionality to provide access to the vaginal canal.
6
There are no existing performance standards to evaluate the functions of the GelPOINT V-Path Vaginal Access System. A protocol was developed by Applied Medical to evaluate the ability of the subject device to provide access to the vaginal canal and remain anchored following deployment. Maintenance of insufflation and device removal were also assessed.
Function Testing
Functional bench testing was performed to demonstrate the adequate functionality of the Vaginal Access System, as follows:
- Maintenance of transvaginal access ●
- Facilitation of instrument access to surgical site ●
- Device removal
- Device retention ●
- Maintenance of insufflation
The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments and can remain anchored in the patient while withstanding conditions under normal clinical use. The studies also confirm that the integrity and sealing capability of the device system are adequate to maintain insufflation as a means to provide visualization of the surgical space.
Biocompatibility
Biocompatibility studies were performed in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and "testing" as follows:
- Cytotoxicity: ISO 10993-5:2009 ●
- Sensitization: ISO 10993-10:2010 .
- Irritation: ISO 10993-10:2010 ●
- Acute Systemic Toxicity: ISO 10993-11:2017
- Pvrogenicity Potential: USP . ISO 10993-11:2017 .
The biocompatibility test results demonstrate the GelPOINT V-Path Vaginal Access System is biocompatible. The results show the subject device has met the criteria to be classified as a non-cytotoxic, non-sensitizer, non-irritant device that shows no sign of being systemically toxic or pyrogenic. The information provided for biocompatibility testing indicate the subject device is acceptable to demonstrate substantial equivalence from a biocompatibility standpoint.
7
Shelf-Life
The GelPOINT V-Path Vaginal Access System has a shelf life of 3 years when packaged in Tyvek and nylon film pouches, in accordance with the results of accelerated aged stability studies. Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration.
Clinical Performance Data
Clinical data are not needed to support substantial equivalence for the subject device.
Conclusion
The GelPOINT V-Path Vaginal Access System has the same intended use as the predicate device. The GelPOINT V-Path Vaginal Access System has different technological characteristics from the predicate device, but these differences do not raise different questions of safety and effectiveness. Performance testing, as described above, demonstrates that the GelPOINT V-Path Vaginal Access System is as safe and effective as the predicate. Therefore, the GelPOINT V-Path Vaginal Access System is substantially equivalent to the predicate device.