DUMI ManipulatOR

K212505 · The O R Company Pty, Ltd. · LKF · Jan 10, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K212505
• Device Name: DUMI ManipulatOR
• Applicant: The O R Company Pty, Ltd.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Jan 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures where manipulation of the uterus is required.

Device Story

DUMI ManipulatOR is a sterile, single-use, disposable uterine manipulator. Device consists of a catheter, handle, and distal apple-shaped balloon. Physician inserts device into uterus; balloon is inflated with air via syringe through a luer connector on an inflation valve. Three-way hub accommodates fluid for dye studies. Device enables manipulation of anteverted and retroverted uteri during gynecological procedures. Used in OR or clinical settings by physicians. Provides mechanical leverage for tissue positioning; facilitates diagnostic visualization and dye studies. Benefits include effective uterine control and simplified procedural workflow.

Clinical Evidence

Bench testing only. No clinical data. Preclinical testing included physical, mechanical, and biocompatibility assessments (cytotoxicity, sensitization, acute systemic toxicity). Performance testing verified balloon capacity, fatigue, burst pressure, air leakage, spring load locking force, component joint strength, tip deflection, and luer connector integrity. All tests met predetermined acceptance criteria.

Technological Characteristics

Sterile, single-use, disposable uterine manipulator. Features include a catheter, handle, and 10cc apple-shaped balloon. Materials are well-characterized and commonly used in medical devices. Connectivity: manual luer connector. Sterilization: ETO (ISO 11135:2014). Standards: ISO 13485, ISO 14971, ISO 10993, ISO 80369-7, ASTM F88, ASTM F1929, ASTM F2096, ASTM F1980, ASTM D4169, ASTM F3172.

Indications for Use

Indicated for patients undergoing diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures requiring uterine manipulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Panpac Uterine Manipulator Injector, Model UMI 4.5 (K092980)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2022

The O.R. Company Pty Ltd Amesha Silva Quality Assurance & Regulatory Affairs Manager 1/32 Silkwood Place Carrum Downs, Victoria 3201 Australia

Re: K212505

> Trade/Device Name: DUMI ManipulatOR (DUMI-350A) Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: November 30, 2021 Received: December 7, 2021

Dear Amesha Silva:

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); 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 ([e-mail]) or phone [phone] 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) K212505

Device Name DUMI ManipulatOR (DUMI-350A)

Indications for Use (Describe)

The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures where manipulation of the uterus is required.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for "The O.R. Company". The logo consists of the text "THE O.R. COMPANY" in a blue sans-serif font, with the "O.R." in white inside of a blue circle. Below the company name is the tagline "The smart way to operate" in a smaller, lighter blue font.

# DUMI ManipulatOR - 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitted by: | The O R Company Pty Ltd |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1/32 Silkwood Rise, Carrum Downs, VIC, 3201, Australia |
| | Phone: [phone] |
| | Fax: + 61 3 9413 5556 |
| Contact Person: | Name: Nicole Conway |
| | Title: Quality Assurance & Regulatory Affairs Manager |
| | Phone number: [phone] |
| | Email: [e-mail] |
| Date Prepared: | 06 January 2022 |
| Device Trade Name: | DUMI ManipulatOR (DUMI-350A) |
| Common name: | Uterine manipulator |
| Classification name: | Obstetric-gynecologic specialized manual instrument |
| Regulation number: | 884.4530 |
| Product Code: | LKF (Class II) - Cannula, Manipulator/Injector, Uterine |
| Panel: | Obstetrics/Gynecology |
| Predicate Devices: | Panpac Medical Corporation ---- Panpac Uterine Manipulator Injector, Model UMI 4.5 (K092980) |
| | The predicate device has not been subjected to a recall. |
| Device Description: | The DUMI ManipulatOR is a sterile, single use, disposable medical device designed for the intra- |
| | operative manipulation of both the anteverted and retroverted uterus as well as facilitating simple |
| | and effective dye studies. |
| | The device includes an anatomically designed balloon at the distal end that is injected with air by |
| | syringe through the luer connector of inflation valve. The three-way hub can accommodate fluid |
| | and can be used for dye studies. |
| Indications for use: | The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility |
| | exams, and salpingoplastic procedures where manipulation of the uterus is required. |
| Substantial Equivalence<br>Discussion: | Indications:<br>The ORC DUMI ManipulatOR and UMI 4.5 have almost identical indications for use. Both devices<br>are used for diagnostic procedures such as laparoscopy, minilaparotomy, fertility examinations and<br>salpingoplastic procedures where manipulation of the uterus is required. There is no difference in<br>intended use.<br><br>Technological characteristics:<br>Both the DUMI ManipulatOR and the UMI 4.5 share almost identical technological characteristics.<br>The designs of both devices consist of a catheter, handle and a balloon to help with manipulation<br>of tissue. The devices have the following differences:<br>There is a 20mm difference in length between DUMI ManipulatOR and UMI 4.5.The shape of the DUMI ManipulatOR balloon is apple shaped while it is elongated for the predicate. They are the same volume (10cc)There are minor differences in handle designThe differences do not raise different questions of safety and effectiveness.<br><br>Performance:<br>As noted in the summary of testing below, the DUMI ManipulatOR was evaluated for performance<br>and demonstrated to be as safe and effective as the predicate. |

| Asia Pacific | North America | Hong Kong | Contact |
|------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------|
| 1/32 Silkwood Rise<br>Carrum Downs, VIC<br>3201, Australia | 1625 South Tacoma Way<br>Tacoma WA, 98409<br>USA | Flat 9/F Wah Kit<br>Commercial Centre<br>300 Des Voeux Road<br>Central Hong Kong | [e-mail]<br>theorcompany.com |
| T [phone]<br>F [phone] | T [phone]<br>F [phone] | T [phone]<br>F [phone] | |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a logo for "THE O.R. COMPANY". The logo consists of the text "THE" followed by a blue circle containing the letters "O.R." in white. To the right of the circle is the text "COMPANY" and below that is the tagline "The smart way to operate".

| Summary of Testing/Data: | The design of The OR Company's DUMI ManipulatOR device is based on Panpac Medical<br>Corporation's Uterine Manipulator Injector (Model UMI 4.5) device. The DUMI ManipulatOR is<br>demonstrated to be substantial equivalent to the Panpac Medical Corporation's Uterine<br>Manipulator Injector (Model UMI 4.5) device. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | A series of preclinical physical, mechanical and biocompatibility tests were performed to assess<br>the safety and effectiveness of The O.R Company Pty Ltd's DUMI ManipulatOR as compared to the<br>predicate. |
| | The tests were conducted in accordance with relevant standards listed below and have successfully<br>met predetermined acceptance criteria: |
| | ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory |
| | purposes |
| | FDA 21 CFR 820 Quality System regulations |
| | ISO 14971: 2019 Medical devices application of risk management to medical devices |
| | ISO 11135:2014 Sterilization of health-care products-ETO Requirements for the development,<br>validation & routine control of a sterilization process for medical device |
| | ISO 11737-1: 2018 Sterilization of Medical devices-Microbiological methods-Part 1: Determination<br>of a population of microorganisms on products |
| | ISO 11737-2: 2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of<br>sterility performed in the definition, validation and maintenance of a sterilization process |
| | ISO 11607-1 : 2019 Packaging for terminally sterilized medical devices Part 1: Requirements for<br>materials, sterile barrier systems and packaging systems |
| | ISO 11607-2: 2019 Packaging for terminally sterilized medical devices Part 2: Validatio n<br>requirements for forming, sealing and assembly processes |
| | ASTM F88 /F88M-15 Standard test method for seal strength of flexible barrier materials. |
| | ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye<br>penetration. |
| | ASTM F2096-11 (2019) Standard Test Method For Detecting Gross Leaks In Packaging By Internal<br>Pressurization (Bubble Test) |
| | ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a<br>risk management process |
| | ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| | ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin<br>sensitization |
| | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity<br>EN 14372:2004 REACH Regulation (EC) No 1907/2006- Non-DEHP |
| | ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| | ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems |
| | ISO 2859-1:1999 Sampling procedures for inspection by attribute - Part 1: Sampling schemes<br>indexed by acceptance quality limit (AQL) for lot-by-lot inspection |
| | ASTM F3172-15 Design verification device size and sample selection for Endovascular devices |
| | ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7:<br>Connectors for intravascular or hypodermic applications |
| | The specific tests undertaken included: |
| | EO Sterilization: |
| | EO Sterilization Validation EO Residues Bacteriostasis and Fungistatis |

| Asia Pacific | North America | Hong Kong | Contact |
|--------------------|-----------------------|--------------------|-----------------------|
| 1/32 Silkwood Rise | 1625 South Tacoma Way | Flat 9/F Wah Kit | [e-mail] |
| Carrum Downs, VIC | Tacoma WA, 98409 | Commercial Centre | theorcompany.com |
| 3201, Australia | USA | 300 Des Voeux Road | |
| | | Central Hong Kong | |
| T [phone] | T [phone] | T [phone] | |
| F [phone] | F [phone] | F [phone] | |

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for "The O.R. Company". The logo is in blue and features the company name in a simple, sans-serif font. Below the company name is the tagline "The smart way to operate".

#### Bioburden ●

### Shelf Life:

- Packaging integrity post 5 year accelerated aging ●
- Performance post 5 year accelerated aging

# Packaging:

- Seal Strength of Flexible Barrier Materials
- Dye Penetration
- Sterility ●

# Transportation:

- Handling
- Loose Load Vibration ●
- Low Pressure (High Alititude) Hazard
- Vehicle Vibration
- Handling

# Biocompatibility:

Both devices are used in the same anatomical site and the same components of both devices come in short term contact with the mucosal membranes of the uterus and the vagina.

All patient contacting components of both devices have been tested for biocompatibility and have been found to be non-toxic, non-sensitizing, non-cytotoxic and non-irritating. The raw materials have all been used in various combinations by not only The O.R Company and predicate devices but also by uterine manipulators currently on the market. The materials are all well-characterized, are all commonly used in these and other medical devices. The following tests were conducted on the subject device:

- . Cytotoxicity
- Sensitization
- Acute Systemic Toxicity ●

The performance tests listed below have demonstrated that The O.R Company Pty Ltd's DUMI ManipulatOR performs at least the same as the predicate device PanPac Medical Corporations UMI 4.5:

- Intrauterine balloon capacity and diameter test
- Intrauterine balloon fatigue test (repeat inflation) ●
- Intrauterine balloon burst test
- Air leakage test for prolonged time ●
- . Spring load locking mechanism force test
- Component joint strength test
- Tip deflection test
- Balloon adhesion strength test
- . Luer connector leakage test

| Conclusion: | The subject device, DUMI ManipulatOR share similar indications and technological characteristics<br>as the predicate device. All tests undertaken to demonstrate substantial equivalence of the DUMI<br>ManipulatOR meet the requirements of its predetermined acceptance criteria. The test results<br>confirm that the The O.R Company Pty Ltd's DUMI ManipulatOR is as safe and effective as the<br>predicate device. Therefore, the DUMI ManipulatOR is substantially equivalent to the<br>predicate. |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Asia Pacific | North America | Hong Kong | Contact |
|--------------------|-----------------------|---------------------------------------|-----------------------|
| 1/32 Silkwood Rise | 1625 South Tacoma Way | Flat 9/F Wah Kit<br>Commercial Centre | [e-mail] |
| Carrum Downs, VIC | Tacoma WA, 98409 | 300 Des Voeux Road | theorcompany.com |
| 3201, Australia | USA | Central Hong Kong | |
| T [phone] | T [phone] | T [phone] | |
| F [phone] | F [phone] | F [phone] | |