(195 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is a surgical tool used to manipulate the uterus and vaginal fornices during laparoscopic procedures. It does not provide any therapeutic effect such as treating or curing a disease. Its function is to facilitate the surgical procedure for the surgeon.
No
The device is described as a surgical instrument used for uterine manipulation during laparoscopic procedures for colpotomy incisions and maintaining pneumoperitoneum. Its function is to physically assist the surgeon, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components made of materials like ABS polymer and stainless steel, and the performance studies focus on mechanical properties, biocompatibility, sterilization, and shelf life of these physical components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use by a surgeon in laparoscopic procedures for uterine manipulation, colpotomy incisions, and maintaining pneumoperitoneum. This is a surgical procedure performed on the patient's body.
- Device Description: The description details a physical device used for manipulation and surgical procedures within the body. It does not describe a device used to examine specimens in vitro (outside of the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.
Product codes (comma separated list FDA assigned to the subject device)
HEW, LKF
Device Description
The Surgitools Pty Ltd. ColpoWave Colpotomizer and CerviGrip Uterine Manipulator consists of the ColpoWave™ Colpotomizer, CerviGrip™ Uterine Manipulator, and the ColpoWave™ Balloon accessory. All parts are made without natural latex rubber and supplied sterile to be disposed of after use.
The single-use CerviGrip™ Uterine Manipulator is designed with an integrated cervical screw, a sliding uterine tip, tail screw that can lock the uterine tip in place, and a screw to hold the colpotomizer in place. The CerviGrip™ Uterine Manipulator is manufactured with ABS polymer and 304 Stainless Steel.
The ColpoWave™ Colpotomizer is non-fenestrated and has incorporated two different sizes due to the double-ended colpotomizer design (30mm or 40mm diameter). Cup shape with one partial circumferential raised lip at each end and a second partial raised circumferential lip 20mm from each end providing the surgeon with a known distance to help gauge pelvic distances during dissection. The ColpoWave™ Colpotomizer is manufactured with green ABS polymer to provide better visualization (greater contrast than white against tissue).
The ColpoWave™ Balloon is an optional accessory, which is inflated to fit various vaginas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, uterus, pelvic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon in laparoscopic procedures
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)
- Performance Testing: The device successfully passed bench testing to evaluate mechanical and functional properties to ensure the device is robust to withstand forces that exceed the expected forces during use, including tensile tests, manipulation, and balloon strength and stability.
- Biocompatibility testing per ISO 10993-1, ISO 10993-10 and ISO 10993-10 and ISO 10993-11: Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity Testing were performed. All tests were conducted on the finished device after manufacturing, packaging, and sterilization had been completed to reflect the actual state of the device when exposed to the patient. All patient-contacting device components passed biocompatibility testing required by ISO 10993-1 and FDA General Program Memorandum G95-1.
- Sterilization Validation: The sterility of the Surgitools Uterine Manipulator and Colpotomizer system is assured by using a validated sterilization method qualified in accordance with ISO 11135-1. The validation results met the acceptance criteria defined in the standard and demonstrates the ability of the process to deliver SAL of 10 °. Examination of the EtO residuals has been conducted in accordance with ISO 10993-7, which has validated a minimum release period of 7 days.
- Shelf Life Testing: After the sterilization cycle was complete, the products were accelerated aged and tested to demonstrate no degradation in strength or functionality over the anticipated shelf life period of three (3) years.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
Surgitools Pty Ltd. % Elizabeth Pugh Regulatory Affairs Consultant Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K161065
Trade/Device Name: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: Class II Product Code: HEW Dated: September 28, 2016 Received: September 28, 2016
Dear Elizabeth Pugh:
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. You must
1
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 (QS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
For Division
Douglas Silverstein -S 2016.10.27 15:26:25 -04'00' 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) K161065
Device Name
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Indications for Use (Describe)
The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.
| 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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510(k) Summary
K161065
1. Submission Sponsor
Surgitools Pty Ltd. 231 Timberlane Dr. Woodvale Western Australia 6026, Australia Phone number: 61-08-93093222 Contact: Jai Singh Title: Director: Global Sales & Marketing
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Rd, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Elizabeth Pugh, Consultant, RA Email: project.management@emergogroup.com
3. Date Prepared
October 14, 2016
4. Device Identification
| Trade/Proprietary Name: | ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator |
|---|---|
| Common/Usual Name: | Uterine Manipulator and Colpotomizer |
| Classification Name: | Culdoscope and accessories |
| Regulation Number: | 884.1640 |
| Product Code: | HEW, Culdoscope and accessories |
| LKF, Cannula, manipulator/injector, uterine | |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Device(s)
K110819, Singh Colpotomizer System, Surgitools Pty Ltd.
6. Device Description
The Surgitools Pty Ltd. ColpoWave Colpotomizer and CerviGrip Uterine Manipulator consists of the ColpoWave™ Colpotomizer, CerviGrip™ Uterine Manipulator, and the ColpoWave™ Balloon
4
accessory. All parts are made without natural latex rubber and supplied sterile to be disposed of after use.
The single-use CerviGrip™ Uterine Manipulator is designed with an integrated cervical screw, a sliding uterine tip, tail screw that can lock the uterine tip in place, and a screw to hold the colpotomizer in place. The CerviGrip™ Uterine Manipulator is manufactured with ABS polymer and 304 Stainless Steel.
The ColpoWave™ Colpotomizer is non-fenestrated and has incorporated two different sizes due to the double-ended colpotomizer design (30mm or 40mm diameter). Cup shape with one partial circumferential raised lip at each end and a second partial raised circumferential lip 20mm from each end providing the surgeon with a known distance to help gauge pelvic distances during dissection. The ColpoWave™ Colpotomizer is manufactured with green ABS polymer to provide better visualization (greater contrast than white against tissue).
The ColpoWave™ Balloon is an optional accessory, which is inflated to fit various vaginas.
7. Indications for Use Statement
The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.
8. Predicate Comparison
The following table compares the Surgitools Colpotomizer and CerviGrip Uterine Manipulator to the predicate device with respect to indications for use, technological characteristics, and materials:
| Trade Name | Singh Colpotomizer System
K110819 (Surgitools Pty Ltd.) | ColpoWave Colpotomizer and CerviGrip
Uterine Manipulator
K161065 (Surgitools Pty Ltd.) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Singh Colpotomizer System is
indicated for use by a surgeon in
laparoscopic procedures requiring
uterine manipulation and the
visualization of the position of the
vaginal fornices for colpotomy incisions
into the vaginal vault. The surgeon
makes the colpotomy incisions to access
or remove intraperitoneal tissue from
the pelvic cavity. | The ColpoWave Colpotomizer and
CerviGrip Uterine Manipulator is
indicated for use by a surgeon in
laparoscopic procedures where uterine
manipulation and visualization of the
position of the vaginal fornices for
colpotomy incisions is required, and for
maintaining pneumoperitoneum during
vaginal vault closure. |
5
| System
Components | Uterine manipulator with cervical
screw attachment; Sliding uterine tip (inner rod); Sliding and rotating funnels
(available in two sizes) with a lip
acting as a colpotomizer; O-ring and screw to hold the
funnel in place; and Vaginal occluder (plastic
vaginal plug) | Uterine manipulator with cervical
screw attachment Sliding uterine tip Sliding and rotating colpotomizer
(incorporating two sizes) ColpoLock and screw to hold the
colpotomizer in place; Pneumatic plug (PneumoBloc); and Vaginal occluder (ColpoWave Balloon |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Uterine Tips | Single length inner rod | Single length inner rod |
| Vaginal Plug | OD 43mm
Length 50mm | ColpoWave Balloon is inflated to fit
various vaginas |
| Design
Colpotomizer | Two colpotomizers of different
sizes. 35mm and 40mm Cup shape with partial
circumferential raised lip at its end. White. Non-fenestrated. | One colpotomizer incorporating two
different sizes. One side diameter
30mm and one of diameter 40mm Cup shape with one partial
circumferential raised lip at each end
and a second partial raised
circumferential lip 20mm from each
end. Green. Non-fenestrated. |
| Uterine
manipulator | Uterine manipulator with cervical
screw attachment; Sliding uterine tip (inner rod); Tail screw with hydrotubation port;
and O-ring and screw to hold the funnel
in place | Uterine manipulator with integrated
cervical screw and hydrotubation
port; Sliding uterine tip; Tail screw that can lock the uterine
tip in place; and ColpoLock and screw to hold
colpotomizer in place. |
| Materials | Stainless steel and polymer | Stainless steel and polymer |
| Single use or reusable | Reusable | Single use |
| Biocompatible materials | Yes | Yes |
The Surgitools ColpoWave Colpotomizer and CerviGrip Uterine Manipulator has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the ColpoWave Colpotomizer and CerviGrip Uterine Manipulator and in showing substantial equivalence to the predicate device, Surgitools Pty Ltd. completed a number of tests and validations. The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator meets all the requirements for overall design, sterilization, and biocompatibility confirming that the design output meets the design inputs and specifications for the device.
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The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
-
Performance Testing
The device successfully passed bench testing to evaluate mechanical and functional properties to ensure the device is robust to withstand forces that exceed the expected forces during use, including tensile tests, manipulation, and balloon strength and stability. -
Biocompatibility testing per ISO 10993-1, ISO 10993-10 and ISO 10993-10 and ISO 10993-11
The subject device is an external communicating device that contacts tissue for less than 24 hours. Cytotoxicity, Intracutaneous Reactivity, Sensitization, and Acute Systemic Toxicity Testing were performed. All tests were conducted on the finished device after manufacturing, packaging, and sterilization had been completed to reflect the actual state of the device when exposed to the patient. All patient-contacting device components passed biocompatibility testing required by ISO 10993-1 and FDA General Program Memorandum G95-1. -
. Sterilization Validation
The sterility of the Surgitools Uterine Manipulator and Colpotomizer system is assured by using a validated sterilization method qualified in accordance with ISO 11135-1. The validation results met the acceptance criteria defined in the standard and demonstrates the ability of the process to deliver SAL of 10 °. Examination of the EtO residuals has been conducted in accordance with ISO 10993-7, which has validated a minimum release period of 7 days. -
Shelf Life Testing
After the sterilization cycle was complete, the products were accelerated aged and tested to demonstrate no degradation in strength or functionality over the anticipated shelf life period of three (3) years.
10. Clinical Performance Data
There was no human clinical testing required to support the substantial equivalence of the subject device.
11. Conclusion
Based on the comparison and analysis above, the Surgitools ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is substantially equivalent to the referenced predicate device.