(133 days)
Not Found
No
The device description and performance studies focus on mechanical manipulation and physical properties, with no mention of AI or ML technologies.
No.
The device is a surgical tool used to manipulate the uterus and maintain pneumoperitoneum during laparoscopic procedures; it does not claim to treat or cure any disease or condition.
No
The device is a surgical tool used for manipulating the uterus during laparoscopic procedures and is not described as providing diagnostic information.
No
The device description clearly states it is a sterile, single-use uterine manipulator made of silicone insulated and anatomically designed stainless steel, with a silicone intrauterine balloon. This describes a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manipulation of the uterus during surgical procedures. This is a physical action performed on the organ itself, not a test or analysis of a biological sample taken from the body.
- Device Description: The description details a physical instrument with a balloon for inflation, designed for surgical manipulation and maintaining pneumoperitoneum. It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is a surgical instrument used for physical manipulation during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus, vagina, cervix
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 product performance testing was successfully completed to confirm the subject device met the user requirements for 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
Per ISO 10993-1, the following biocompatibility tests were conducted and confirmed all direct body materials used in the subject device are biocompatible for the proposed intended use:
• MEM Elution Cytoxicity
• Mucosal (vaginal) Irritation
• Guinea Pig Maximization Sensitization
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
§ 884.4530 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized eagle or bird symbol. The bird symbol is composed of three overlapping profiles, suggesting a sense of community or interconnectedness. The overall design is simple and professional, reflecting the department's role in public health and human services.
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
1
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 Ltd
Unit 7, 6-8 Macquarie Drive, Thomastown 3074, Australia
Phone: +61 3 9413 5555 |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact email: qa@gynetech.com.au
Fax: +61 3 9413 5555 |
| Contact Person | Kevin MacDonald
Clinical/Regulatory Consultant
229 Marvilla Circle
Pacifica, CA 94044
Phone: 415-609-9875 |
| Date Prepared: | Email: k-macdonald@sbcglobal.net
December 15, 2014 |
| | |
| Proprietary Name: | ManipulatOR, ManipulatOR PRO |
| Common Name: | Uterine elevator; uterine manipulator |
| Classification: | LKF, Unclassified, Pre-Amendment
Cannula, Manipulator/Injector, Uterine |
| Predicate Devices: | Primary Predicate Device: ConMed, VCare Vaginal-Cervical
Ahluwalia's Retractor-Elevator, K071907 |
| Device Description: | 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. |
| Indications for Use: | 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. |
| Summary of
Performance Data | The following product performance testing was successfully
completed to confirm the subject device met the user requirements
for 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 Safety
Data/Biocompatibility
Testing | Per ISO 10993-1, the following biocompatibility tests were
conducted and confirmed all direct body materials used in the
subject device are biocompatible for the proposed intended use:
• MEM Elution Cytoxicity
• Mucosal (vaginal) Irritation
• Guinea Pig Maximization Sensitization |
| Substantial Equivalence
Discussion: | The subject and predicate devices do not have the same
indication statement but have the same intended use
(manipulations of the uterus during laparoscopic procedures).
The differences do not raise any concerns, because the subject
devices have narrowed indications compared to the predicate
device. |
| | The ManipulatOR PRO and predicate device have the same
fundamental technological characteristics, including the
following:
• 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 to
maintain pneumoperitoneum and prevent abdominal
deflation.
The ManipulatOR and predicate device have the following
same 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 cup
compared to the predicate device. However, the differences do not
raise safety and effectiveness concerns, because ManipulatOR may
be used with the access tube if maintenance of pneumoperitoneum
is needed. |
| | The subject devices are different from the predicate device
in that they are not designed for injection of fluids or gases
into the uterus. The difference does not raise safety and
effectiveness concerns, because the subject devices are not
indicated for injection of fluids or gases into the uterus. |
| | The subject and predicate devices use different materials in the
balloon and other patient contact components. The different
materials raise concerns on biocompatibility and mechanical
performance of the subject devices. However, these concerns
do not represent new types of safety and effectiveness
questions. Accepted scientific methods exist for assessment of
the difference (e.g., biocompatibility testing for safety and
bench testing for mechanical performance). The
biocompatibility and bench testing demonstrated that the
subject devices are safe and effective. |
| Conclusion: | The ManipulatOR and ManipulatOR PRO share most technological
and design features and functions with the predicate device. The
performance testing show the safety and functionality of the
Gynetech devices. In summary, the Gynetech ManipulatOR and
ManipulatOR PRO are substantially equivalent to the predicate
devices, ConMed VCare Vaginal-Cervical Ahluwalia's Retractor-
Elevator. |
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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.