(115 days)
Not Found
No
The summary describes a mechanical device for surgical access and does not mention any AI/ML components or capabilities.
No
The device is described as an access platform for instruments, maintaining insufflation, and specimen extraction during surgical procedures, which are functions that facilitate a surgical procedure rather than directly treating a disease or condition.
No
The device is described as an access platform for surgical instruments and specimen extraction, not for diagnosing medical conditions. Its function is to facilitate minimally invasive surgical procedures, not to identify diseases or conditions.
No
The device description clearly outlines physical components like an access channel, GelSeal cap, and sleeves, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical access and instrument manipulation during gynecological procedures. This is a surgical device, not a diagnostic one.
- Device Description: The description details a physical platform, cap, and sleeves for surgical access and insufflation. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on sterilization, shelf life, biocompatibility, mechanical performance (maintaining access, insufflation, etc.), and clinical outcomes of surgical procedures. There are no studies related to diagnostic accuracy or the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring specific substances or markers for diagnostic purposes.
In summary, the device is designed to facilitate surgical procedures, not to provide diagnostic information based on the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.
Product codes (comma separated list FDA assigned to the subject device)
HEW
Device Description
The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel 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 laparoscopic 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
transvaginally to create a pathway to gynecological organs in the pelvic cavity
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)
The following performance testing was provided to support a substantial equivalence determination:
- Sterilization validation
- Shelf life testing including transportation simulation, package integrity, and device functionality testing
- Biocompatibility including cytotoxicity per ISO 10993-5 and irritation and sensitization testing per ISO 10993-10
- Mechanical performance testing including assessments of the following:
- Maintenance of transvaginal access
- Facilitation of instrument access to surgical site
- Device removal
- Device retention
- Maintenance of insufflation
- Clinical performance data
- Baekelandt et al (2018) - randomized, single-center, single-blinded trial to compare hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) (n=70)
- Orifice -International Natural Transluminal Endoscopic Surgerv (iNOTESs) Society Registry data (n=906)
- Both data sets demonstrated acceptable rates of peri- and post-operative complications following use of the subject 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
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2019
Applied Medical Resources Corp. Corinne Yestrepsky Regulatory Affairs Specialist II 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
Re: K191294 Trade/Device Name: Transvaginal Access Platform Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope And Accessories Regulatory Class: II Product Code: HEW Dated: August 2, 2019 Received: August 7, 2019
Dear Corinne Yestrepsky:
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. 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
1
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,
for Sharon M. Andrews Acting 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
Enclosure
2
Indications for Use
510(k) Number (if known) K191294
Device Name Transvaginal Access Platform
Indications for Use (Describe)
The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.
| 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) |
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3
510(k) Summary – K191294
| 510(K) Submitter: | Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Corinne Yestrepsky, PhD
Regulatory Affairs Specialist II
Applied Medical Resources Corp.
Corinne. Yestrepsky@appliedmedical.com
Tel: (949) 713-8176
Fax: (949) 713-8205 |
| Date of Preparation: | September 6, 2019 |
| Trade Name: | Transvaginal Access Platform |
| Common Name: | Transvaginal endoscopic surgery access port |
| Classification: | Regulation: 21 CFR 884.1640, Culdoscope & Accessories
Device Class: Class II
Product Code: HEW (culdoscope and accessories) |
| Predicate Device: | Trade Name: GelPOINT Transvaginal Access Platform
510(k) #: K143308
Product Code: HEW
The predicate device has not been subject to a design related recall. |
| Device Description: | The Transvaginal Access Platform consists of an access channel
component that is placed transvaginally to create a pathway to
gynecological organs in the pelvic cavity. A GelSeal cap
attaches to the access channel 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
laparoscopic instrumentation. Visualization is achieved via
introduction of an endoscope through a sleeve. The device is
provided sterile. |
| Indications for use: | The Transvaginal Access Platform is intended to be inserted
transvaginally to establish a path of entry for minimally invasive
instruments while maintaining insufflation during laparoscopic-
assisted and vaginal gynecological procedures. The device is
also a conduit for the extraction of specimens. |
4
Comparison with the Predicate Device
The subject and predicate device have different indications for use statements. The predicate device is indicated only for laparoscopic hysterectomy, while the subject device is indicated for laparoscopic assisted and vaginal gynecologic procedures. The key difference is that the subject device can be used during a procedure that only relies on vaginal access (i.e., no laparoscopic access), as well as laparoscopic-assisted gynecologic procedures other than hysterectomy. In addition, the subject device indication uses the term "maintaining insufflation" versus the "maintaining pneumoperitoneum" term used in the predicate device indication. This change in terminology is to account for insufflation of the vaginal canal when the subject device is in use.
The subject and predicate device have the same intended use - establishing a path of entry for instruments, maintaining insufflation, and serving as a conduit for extraction of specimens during minimally invasive gynecologic procedures.
The subject and predicate device have different technological characteristics, including device retention, instrument compatibility, specimen removal method and size, device removal, and device materials. These differences in technological characteristics do not raise different questions of safety or effectiveness.
Discussion of Performance Data
The following performance testing was provided to support a substantial equivalence determination:
- Sterilization validation
- . Shelf life testing including transportation simulation, package integrity, and device functionality testing
- Biocompatibility including cytotoxicity per ISO 10993-5 and irritation and ● sensitization testing per ISO 10993-10
- Mechanical performance testing including assessments of the following:
- Maintenance of transvaginal access o
- Facilitation of instrument access to surgical site o
- Device removal O
- o Device retention
- Maintenance of insufflation o
- Clinical performance data
- o Baekelandt et al (2018) - randomized, single-center, single-blinded trial to compare hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) (n=70)
- Orifice -International Natural Transluminal Endoscopic Surgerv o (iNOTESs) Society Registry data (n=906)
- Both data sets demonstrated acceptable rates of peri- and post-operative o
5
complications following use of the subject device.
Conclusion
Based on the intended use, technological characteristics, and performance testing results, the subject Transvaginal Access Platform device is considered substantially equivalent to the predicate device.