(133 days)
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device. The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.
This document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO. It details the device's indications for use, its description, and a summary of performance and safety data, as well as a substantial equivalence discussion.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., "device must withstand N newtons of force"). Instead, it lists various performance tests and indicates that they were "successfully completed to confirm the subject device met the user requirements for the proposed intended use." The reported device performance is qualitative, confirming that the tests were passed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain system and balloon integrity during "worst" case conditions (Air Leak) | Air Leak Test – inflation of the balloon confirmed system and balloon integrity would be maintained during "worst" case conditions. |
| Balloon integrity when exposed to maximum inflation volume | Balloon destructive testing - Balloon integrity when exposed to maximum inflation volume was successful. |
| Correlation of balloon inflated diameter and infused balloon volume | Repeat inflation/deflation of balloon and correlation of balloon inflated diameter and infused balloon volume were successfully completed. |
| Durability of critical bonds | Tensile Testing of all critical bonds was successfully completed. |
| Durability of entire system | Tensile Testing of entire system was successfully completed. |
| Compatibility with McCartney Tube (for ManipulatOR PRO) | Compatibility of ManipulatOR PRO with McCartney Tube was successfully completed. |
| Tip deflection force | Force required for tip deflection testing was successfully completed. |
| Clamping forces (for ManipulatOR PRO) | Locking forces of clamp on ManipulatOR PRO testing was successfully completed. |
| Ease of movement when clamp is unlocked (for ManipulatOR PRO) | Ease of movement of ManipulatOR PRO when clamp is unlocked testing was successfully completed. |
| Resistance to aging | Accelerated age testing was successfully completed. |
| Packaging integrity | Packaging validation testing was successfully completed. |
| Biocompatibility with direct body materials | Per ISO 10993-1, biocompatibility tests (MEM Elution Cytoxicity, Mucosal (vaginal) Irritation, Guinea Pig Maximization Sensitization) were conducted and confirmed all direct body materials are biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the various performance tests (e.g., number of devices tested for air leak, balloon integrity, etc.). The provenance of the data is from Gynetech Pty Ltd, an Australian company. The studies appear to be prospective bench testing and biocompatibility testing, conducted by the manufacturer to demonstrate device performance. This is not clinical data, but rather engineering and laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data is derived from technical bench tests and biocompatibility testing, not from expert review of data that would require "ground truth" establishment in the traditional sense of clinical studies.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are bench tests and biocompatibility assessments, not clinical studies involving expert adjudication of findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes technical performance testing and biocompatibility assessment, not a clinical study involving human readers or AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone performance study of an algorithm was not done. This device is a physical medical instrument, not an AI or software device. The listed studies focus on the physical and material performance of the uterine manipulator.
7. Type of Ground Truth Used
The "ground truth" for the performance studies described would be based on engineering specifications, material science standards (e.g., ISO 10993-1 for biocompatibility), and established test protocols to determine if the device meets its design requirements. This is not clinical "ground truth" like pathology or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, and the described studies are not machine learning or AI-based; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
Gynetech, PTY. LTD. % Kevin MacDonald Regulatory Consultant MacDonald Consulting 229 Marvilla Circle Pacifica, CA 94044
Re: K142164
Trade/Device Name: ManipulatOR and ManipulatOR PRO Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: November 17, 2014 Received: November 19, 2014
Dear Kevin MacDonald,
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 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
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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,
Herbert P. Lerner -S
for
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) K142164
Device Name Gynetech ManipulatOR PRO and ManipulatOR
Indications for Use (Describe)
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo and contact information for Gynetech Pty Ltd. The logo features the word "gynetech" in blue, with a stylized blue "g" made of dots to the right. The contact information includes the company's address as Unit 7, 6-8 Macquarie Drive, Thomastown VIC 3074, Australia, as well as their phone number (+61 3 9413 5555), fax number (+61 3 9431 5556), and email address (qa@gynetech.com.au).
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92(c).
| Submitted by: | Gynetech Pty LtdUnit 7, 6-8 Macquarie Drive, Thomastown 3074, AustraliaPhone: +61 3 9413 5555 |
|---|---|
| Contact email: qa@gynetech.com.auFax: +61 3 9413 5555 | |
| Contact Person | Kevin MacDonaldClinical/Regulatory Consultant229 Marvilla CirclePacifica, CA 94044Phone: 415-609-9875 |
| Date Prepared: | Email: k-macdonald@sbcglobal.netDecember 15, 2014 |
| Proprietary Name: | ManipulatOR, ManipulatOR PRO |
| Common Name: | Uterine elevator; uterine manipulator |
| Classification: | LKF, Unclassified, Pre-AmendmentCannula, Manipulator/Injector, Uterine |
| Predicate Devices: | Primary Predicate Device: ConMed, VCare Vaginal-CervicalAhluwalia's Retractor-Elevator, K071907 |
| Device Description: | The ManipulatOR and ManipulatOR PRO are sterile, single-useuterine manipulators indicated for uterine manipulation andpreventing loss of pneumoperitoneum during laparoscopicgynecology procedures. The ManipulatOR and ManipulatOR PRO aresilicone insulated and anatomically designed stainless steelmanipulators with a silicone intrauterine balloon at one end and anexternal handle at the other end. The balloon is inflated with airusing a 20cc syringe that is supplied with the device.The ManipulatOR and ManipulatOR PRO are designed to improvephysician visibility of the uterus and cervix during various medicalexaminations and procedures. Like many uterine elevators currently |
| in the market place, the ManipulatOR and ManipulatOR PRO aredesigned for use in surgical procedures requiring cervical uterinemotions with elevation and retraction of the vaginal fornices. TheManipulatOR and ManipulatOR PRO can help to create the tensionon the tissue to assist in ligament dissection. In the most commonlyused procedure, the total laparoscopic hysterectomy, the uterineelevator must expose the fornix and seal the vagina followingremoval of the uterus. | |
| Indications for Use: | The ManipulatOR is indicated for manipulation of the uterus duringlaparoscopic procedures including laparoscopic assisted vaginalhysterectomy (LAVH), laparoscopic tubal occlusion, and diagnosticlaparoscopy. The ManipulatOR, when used together with theMcCartney Tube, is indicated for manipulation of the uterus duringlaparoscopic procedures requiring maintenance ofpneumoperitoneum, such as total laparoscopic hysterectomy (TLH).The ManipulatOR PRO is indicated for manipulation of the uterusduring laparoscopic procedures such as laparoscopic assisted vaginalhysterectomy (LAVH), total laparoscopic hysterectomy (TLH),laparoscopic tubal occlusion and diagnostic laparoscopy. TheManipulatOR PRO maintains pneumoperitoneum by sealing thevagina once colpotomy is performed. |
| Summary ofPerformance Data | The following product performance testing was successfullycompleted to confirm the subject device met the user requirementsfor the proposed intended use:Air Leak Test – inflation of the balloon to confirm the system and balloon integrity would be maintained during "worst"case conditions. Balloon destructive testing - Balloon integrity when exposed to maximum inflation volume. Repeat inflation/deflation of balloon Correlation of balloon inflated diameter and infused balloon volume Tensile Testing of all critical bonds Tensile Testing of entire system Compatibility of ManipulatOR PRO with McCartney Tube Force required for tip deflection Locking forces of clamp on ManipulatOR PRO Ease of movement of ManipulatOR PRO when clamp is unlocked. Accelerated age testing Packaging validation testing |
| Summary of SafetyData/BiocompatibilityTesting | Per ISO 10993-1, the following biocompatibility tests wereconducted and confirmed all direct body materials used in thesubject device are biocompatible for the proposed intended use:• MEM Elution Cytoxicity• Mucosal (vaginal) Irritation• Guinea Pig Maximization Sensitization |
| Substantial EquivalenceDiscussion: | The subject and predicate devices do not have the sameindication statement but have the same intended use(manipulations of the uterus during laparoscopic procedures).The differences do not raise any concerns, because the subjectdevices have narrowed indications compared to the predicatedevice. |
| The ManipulatOR PRO and predicate device have the samefundamental technological characteristics, including thefollowing:• A rigid, anatomically curved manipulator shaft• A balloon at distal end of the shaft• A valve and handle at proximal end of the shaft• A cervical cup• A vaginal cup• A clamp to secure the vaginal cup• The vaginal cup seals the vaginal cavity from within tomaintain pneumoperitoneum and prevent abdominaldeflation.The ManipulatOR and predicate device have the followingsame fundamental technological characteristics:• A rigid, anatomically curved manipulator shaft• A balloon at distal end of the shaft• A valve and handle at proximal end of the shaft | |
| The ManipulatOR does not have the cervical cup and vaginal cupcompared to the predicate device. However, the differences do notraise safety and effectiveness concerns, because ManipulatOR maybe used with the access tube if maintenance of pneumoperitoneumis needed. | |
| The subject devices are different from the predicate devicein that they are not designed for injection of fluids or gasesinto the uterus. The difference does not raise safety andeffectiveness concerns, because the subject devices are notindicated for injection of fluids or gases into the uterus. | |
| The subject and predicate devices use different materials in theballoon and other patient contact components. The differentmaterials raise concerns on biocompatibility and mechanicalperformance of the subject devices. However, these concernsdo not represent new types of safety and effectivenessquestions. Accepted scientific methods exist for assessment ofthe difference (e.g., biocompatibility testing for safety andbench testing for mechanical performance). Thebiocompatibility and bench testing demonstrated that thesubject devices are safe and effective. | |
| Conclusion: | The ManipulatOR and ManipulatOR PRO share most technologicaland design features and functions with the predicate device. Theperformance testing show the safety and functionality of theGynetech devices. In summary, the Gynetech ManipulatOR andManipulatOR PRO are substantially equivalent to the predicatedevices, ConMed VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator. |
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Image /page/4/Picture/0 description: The image contains the logo for Gynetech. The word "gynetech" is written in lowercase letters, with "gyne" in blue and "tech" in gray. To the right of the text is a stylized blue letter "g" surrounded by a dotted pattern.
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Image /page/5/Picture/0 description: The image shows the logo for Gynetech. The word "gynetech" is written in lowercase letters, with "gyne" in blue and "tech" in gray. To the right of the word is a blue circle made of dots, with a stylized "g" in the center.
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Image /page/6/Picture/0 description: The image shows the logo for Gynetech. The word "gynetech" is written in lowercase letters, with "gyne" in blue and "tech" in gray. To the right of the word is a blue circle made of dots, with a white "g" in the center.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.