(66 days)
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML components or algorithms.
No.
The device is used for manipulation, fluid/gas injection, and maintaining pneumoperitoneum during surgical procedures, rather than for treating or curing a disease or condition.
No.
Explanation: The device is described as being used for "manipulation of the uterus, and injection of fluids or gases" during various laparoscopic procedures, including "diagnostic laparoscopy." While it can be used during a diagnostic procedure, its function is described as manipulation and fluid/gas injection, not for diagnosing a condition itself. It's a surgical tool that facilitates other procedures, some of which may be diagnostic in nature.
No
The device description clearly outlines physical components such as a stainless steel shaft, intrauterine balloon, external handle, vaginal cup, cervical cup, and an occluder balloon. It is a physical medical device, not software-only.
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 used for manipulating the uterus and injecting fluids/gases during laparoscopic surgical procedures. This is a direct intervention on the patient's body for surgical purposes.
- Device Description: The description details a physical device with a shaft, balloons, cups, and ports designed for mechanical manipulation and fluid delivery within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used outside the body to analyze samples.
The device is a surgical instrument used in vivo (within the living body) during surgical procedures, not an in vitro diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mucosal Membranes- Uterus and 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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1: 2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The subject device underwent the following tests:
- Cytotoxicity per ISO 10993-5:2009
- Irritation per ISO 10993-10:2010
- Sensitization per ISO 10993-5:2010
- Acute Systemic toxicity per ISO 10993-11:2017
- Pyrogenicity per ISO 10993-11 and USP
The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours.
Performance & mechanical testing:
The following performance and mechanical tests demonstrated that the subject device performs substantially equivalent to the predicate device:
- Intrauterine balloon integrity & concentric inspection
- Intrauterine balloon inflation stability test for a defined time period.
- Intrauterine balloon burst test
- Intrauterine balloon fatigue test
- Intrauterine balloon adhesion strength test
- OccludOR balloon outer diameter inspection & leakage free test
- OccludOR balloon deflation time test
- OccludOR balloon capacity test- reliability/safety
- OccludOR balloon fatigue durability test
- OccludOR balloon burst test
- Vaginal cup air leakage test
- Cervical cup temperature test
- Air inflation valve test
- Dye-injection port compliance & leakage test
- Thumb screw strength test
- Locking force test of vaginal cup
- Ease of movement of vaginal cup along the shaft
- Cervical cup detachment force test
- Cervical cup stopper adhesion strength test
- Device tensile strength
- Handle joint strength
- Tip deflection
- Ultrasonic welding strength
Key Results: In all testing, the subject device met the pre-specified acceptance criteria. The test results demonstrate that the subject device is as safe and effective as the predicate 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.
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.
0
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March 31, 2022
The O R Company Pty Ltd Nicole Conway Quality Assurance & Regulatory Affairs Manager 1/32 Silkwood Rise Carrum Downs, Victoria 3201 Australia
Re: K220202
Trade/Device Name: Uterine ElevatOR PRO with OccludOR Balloon™ Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: January 28, 2022 Received: February 3, 2022
Dear Nicole Conway:
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
Enclosure
2
Indications for Use
510(k) Number (if known) K220202
Device Name
Uterine ElevatOR PRO with OccludOR Balloon TM
Indications for Use (Describe)
The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectorny, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperioneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.
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
Image /page/3/Picture/1 description: The image is a logo for "THE O.R. COMPANY". The words "THE" and "COMPANY" are in a blue sans-serif font, with "O.R." in a blue circle. Below the company name is the tagline "The smart way to operate".
Image /page/3/Picture/2 description: The image shows the logo for Symmetry Surgical Company. The logo features a stylized red and gray shape to the left of the text. The text reads "symmetry surgical" in a gray sans-serif font, with the word "company" in a smaller font size to the right.
Image /page/3/Picture/3 description: The image shows the word "Bovie" in a sans-serif font. The word is in a dark blue color. Above the word is a light blue curved line with a dot at the end. The registered trademark symbol is to the right of the word.
Uterine ElevatOR PRO with OccludOR Balloon™ - 510(k) Summary
l. SUBMITTER
The O R Company Pty Ltd 1/32 Silkwood Rise, Carrum Downs, VIC 3201, Australia Phone: +61 3 9413 5555 Fax: + 61 3 9413 5556
Contact Person: Nicole Conway Email: nicole@theorcompany.com Date Prepared: January 19, 2022
II. DEVICE
Trade Name: Uterine ElevatOR PRO with OccludOR Balloon™ Model numbers: UE-OBPRO-32, UE-OBPRO-35, UE-OBPRO-37 and UE-OBPRO-40 Common Name: Uterine Manipulator / Injector Regulation Number: 21 CFR 884.4530 Classification Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF
III. PREDICATE DEVICE
Conmed Corporation, VCARE (Vaginal-Cervical Ahluwalia's Retractor-Elevator), K142716
This predicate has not been subject to a design-related recall.
Reference devices:
Coopersurgical, Inc., Koh Colpotomizer System, K954311
IV. DEVICE DESCRIPTION
The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces
Asia Pacific
4
Image /page/4/Picture/0 description: The image shows the logo for Symmetry Surgical Company. The logo features the words "symmetry surgical" in a sans-serif font, with the word "company" in a smaller font size to the right. To the left of the text is a red and gray graphic element.
Image /page/4/Picture/2 description: The image shows the logo for "THE O.R. COMPANY". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".
leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.
V. INDICATIONS FOR USE
The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.
| Attributes | Uterine ElevatOR
PRO with
OccludOR Balloon
K220202 | VCARE® Vaginal-
Cervical-
Ahluwalia's-
Retractor-
Elevator K142716 | Discussion |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | The O R Company Pty
Ltd | CONMED
Corporation | --- |
| Class | II | II | Same |
| Regulation Number | 884.4530 | 884.4530 | Same |
| Regulation Generic Name | Cannula,
Manipulator/Injector,
Uterine | Cannula,
Manipulator/Injector,
Uterine | Same |
| Indications for Use | The Uterine ElevatOR
PRO with OccludOR
Balloon™is indicated
for manipulation of
the uterus, and
injection of fluids or
gasses during
laparoscopic
procedures including
total laparoscopic
hysterectomy,
laparoscopic assisted
vaginal
hysterectomy,
laparoscopic tubal
occlusion, and
diagnostic
laparoscopy. The
Uterine ElevatOR
PRO with OccludOR
Balloon™ maintains
pneumoperitoneum
during laparoscopic | The ConMed VCARE®
Retractor/Elevator is
indicated for
manipulation of the
uterus and injection
of fluids or gases
during laparoscopic
procedures such as
Laparoscopic
Assisted Vaginal
Hysterectomy
(LAVH), Total
Laparoscopic
Hysterectomy (TLH),
minilap, laparoscopic
tubal occlusion, or
diagnostic
laparoscopy and also
maintains
pneumoperitoneum
by sealing the vagina
once a colpotomy is
performed. | Same |
| | procedures by
sealing the vagina
once colpotomy is
performed. | | |
| Sterile | Yes, Ethylene Oxide | Yes, Ethylene Oxide | Same |
| Prescription Use | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Intrauterine Balloon inflation volume | 7 – 10 сс | 7 – 10 сс | Same |
| Intrauterine Balloon inflation method | The intrauterine
balloon is inflated by
passing air from a
syringe through a
pilot balloon located
at the distal end of
the device. Inflation
is maintained by a
one-way valve
positioned in the
pilot balloon. The
pilot balloon also
serves as an indicator
of intrauterine
balloon inflation. | The intrauterine
balloon is inflated by
passing air from a
syringe through a
pilot balloon located
at the distal end of
the device. Inflation
is maintained by a
one-way valve
positioned in the
pilot balloon. The
pilot balloon also
serves as an indicator
of intrauterine
balloon inflation. | Same |
| Occluder Balloon | Yes | No | Different |
| Mode of action | Mechanical device
positioning prior to
performing indicated
laparoscopic
procedures | Mechanical device
positioning prior to
performing indicated
laparoscopic
procedures | Same |
| Rigid, insulated and anatomically
curved shaft | Yes | Yes | Same |
| Handle at the distal [to patient] end | Yes | Yes | Same |
| Intrauterine balloon at proximal end
[to patient] end | Yes | Yes | Same |
| Intrauterine balloon material | PVC | PVC | Same |
| Device Components | Direct patient
contacting:
Plug cap
Intrauterine Balloon
Intrauterine Balloon
Colorant
Heat-shrink on the
shaft
Stopper on the shaft
Graduation marking
Cervical cup | Direct patient
contacting:
Intrauterine Balloon
Intrauterine Balloon
Colorant
Heat-shrink on the
shaft
Stopper on the shaft
Graduation marking
Cervical cup
Vaginal Cup | Similar |
| | OccludOR balloon
OccludOR balloon
inflation line
Non-contacting:
Shaft
Thumbscrew &
locking assembly
Thumbscrew &
locking assembly
colorant
Handle
Pilot balloon
Air inflation valve
Air Inflation line
Dye Injection port
Dye Injection port
cap
Robert Clamp
Inflation port for
OccludOR balloon | Non-contacting:
Shaft
Thumbscrew &
locking assembly
Thumbscrew &
locking assembly
colorant
Handle
Pilot balloon
Air inflation valve
Air Inflation line
Dye Injection port
Dye Injection port
cap | |
| Anatomical site | Mucosal
Membranes- Uterus
and Vagina | Mucosal
Membranes- Uterus
and Vagina | Same |
| Contact Period | Short-term contact
(≤24 hours) | Short-term contact
(≤24 hours) | Same |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
Asia Pacific
T +61 3 9413 5555 F +61 3 9413 5556
North America
USA
3034 Owen Drive T +1 800-251-3000 Antioch TN, 37013 F +1 800-342-3272
Contact
info@theorcompany.com theorcompany.com
5
Image /page/5/Picture/0 description: The image shows the logo for "THE O.R. COMPANY". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".
Image /page/5/Picture/1 description: The image shows the logo for Asymmetry. The logo consists of the letter A followed by a stylized letter S. The letter S is split into two parts, with the top part being gray and the bottom part being red. The word "symmetry" is written in gray to the right of the letter S.
symmetry surgical" company
vie.
Asia Pacific
T +61 3 9413 5555
F +61 3 9413 5556
North America
3034 Owen Drive
Antioch TN, 37013
USA
T +1 800-251-3000
F+1 800-342-3272
Contact
info@theorcompany.com theorcompany.com
6
Image /page/6/Picture/0 description: The image is a logo for "THE O.R. COMPANY". The company name is in blue font, with the "O.R." in a blue circle. Below the company name is the tagline "The smart way to operate".
Image /page/6/Picture/1 description: The image shows the logo for Symmetry Surgical. The logo consists of the letter "A" followed by a stylized "S" made up of two curved shapes, one red and one gray. To the right of the logo is the text "symmetry surgical" in a gray sans-serif font.
Both the subject and predicate devices are sterile, single-use medical devices used to manipulate the uterus and cervix in surgical and diagnostic procedures. At a high level, the subject and predicate devices are based on the following same technological elements:
- An anatomically contoured shaft. ●
- An intrauterine balloon at the proximal [to patient] end, a handle at the distal end. ●
- A cervical cup and a vaginal cup.
- . A locking mechanism to secure the vaginal cup in position.
- An inflation line for the intrauterine balloon.
- A dye injection port at the distal end of the handle. ●
The following technological differences exist between the subject and predicate devices:
- The subject device includes the OccludOR Balloon, which is similar to a feature of ● the Colpo-Pneumo Occluder device cleared under K954311.
These differences do not raise different questions of safety and effectiveness as compared to the predicate.
Asia Pacific
3201, Australia
1/32 Silkwood Rise T +61 3 9413 5555
USA
3034 Owen Drive T +1 800-251-3000 Antioch TN, 37013 F +1 800-342-3272 Contact
7
Image /page/7/Picture/0 description: The image shows the logo for "THE O.R. COMPANY". The "O.R." is inside of a blue circle. Below the company name is the tagline "The smart way to operate".
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1: 2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The subject device underwent the following tests:
- Cytotoxicity per ISO 10993-5:2009
- Irritation per ISO 10993-10:2010
- Sensitization per ISO 10993-5:2010
- Acute Systemic toxicity per ISO 10993-11:2017
- Pyrogenicity per ISO 10993-11 and USP
The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours.
Performance & mechanical testing
The following performance and mechanical tests demonstrated that the subject device performs substantially equivalent to the predicate device:
- Intrauterine balloon integrity & concentric inspection ●
- Intrauterine balloon inflation stability test for a defined time period.
- Intrauterine balloon burst test
- Intrauterine balloon fatigue test ●
- Intrauterine balloon adhesion strength test ●
- OccludOR balloon outer diameter inspection & leakage free test
- OccludOR balloon deflation time test
- OccludOR balloon capacity test- reliability/safety
- OccludOR balloon fatigue durability test
- OccludOR balloon burst test
- Vaginal cup air leakage test
- Cervical cup temperature test
- Air inflation valve test
- Dye-injection port compliance & leakage test
- Thumb screw strength test
- Locking force test of vaginal cup
- Ease of movement of vaginal cup along the shaft ●
- Cervical cup detachment force test
- Cervical cup stopper adhesion strength test ●
Asia Pacific
North A
8
Image /page/8/Picture/0 description: The image shows the logo for "The O.R. Company". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".
symmetry surgical" company
- . Device tensile strength
- . Handle joint strength
- . Tip deflection
- Ultrasonic welding strength
In all testing, the subject device met the pre-specified acceptance criteria.
Conclusion:
The intended use of the subject device is identical to the predicate device. The subject device has similar technological characteristics to the predicate device. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. All testing undertaken to demonstrate substantial equivalence of the subject device meet the predetermined acceptance criteria. The test results demonstrate that the subject device is as safe and effective as the predicate device.
Asia Pacific
North America
3034 Owen Drive Antioch TN, 37013 USA
T +1 800-251-3000 F +1 800-342-3272 Contact
info@theorcompany.com theorcompany.com