DUMI ManipulatOR

• K Number: K212505
• Device Name: DUMI ManipulatOR
• Manufacturer: The O R Company Pty Ltd
• Date Cleared: 2022-01-10 ( 154 days)
• Product Code: LKF
• Regulation Number: 884.4530
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: K092980
• Predicate For: N/A

Intended 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 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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines various tests conducted to demonstrate the safety and effectiveness of the DUMI ManipulatOR, primarily by establishing substantial equivalence to a predicate device. The acceptance criteria are generally "successfully met predetermined acceptance criteria" or demonstrating performance "at least the same as the predicate device." Specific numerical criteria are not always explicitly stated in this summary, but the types of tests and their successful outcome are.

Test Category	Specific Test	Acceptance Criteria (as stated or implied)	Reported Device Performance
General Compliance	Compliance with ISO 13485:2016, 21 CFR 820	Requirements for regulatory purposes met	Successfully met
	ISO 14971:2019 (Risk Management)	Application of risk management to medical devices	Successfully met
Sterilization	EO Sterilization Validation	Requirements for development, validation, and routine control of sterilization process	Successfully met
	EO Residues	Acceptable residue levels	Successfully met
	Bacteriostasis and Fungistatis	No unacceptable growth	Successfully met
	Bioburden	Acceptable bioburden levels	Successfully met
	Sterility Test (ISO 11737-2)	Demonstrated sterility	Successfully met
Shelf Life	Packaging integrity post 5 year accelerated aging	Maintain integrity	Successfully met
	Performance post 5 year accelerated aging	Maintain intended performance	Successfully met
Packaging	Seal Strength (ASTM F88)	Acceptable seal strength	Successfully met
	Dye Penetration (ASTM F1929)	No leaks	Successfully met
	Gross Leaks (ASTM F2096)	No gross leaks	Successfully met
	Packaging for terminally sterilized medical devices (ISO 11607-1, ISO 11607-2)	Requirements for materials, sterile barrier systems, packaging systems, formation, sealing, assembly	Successfully met
Transportation	Handling, Loose Load Vibration, Low Pressure (High Altitude) Hazard, Vehicle Vibration	Withstand transportation stresses without damage or compromise to device	Successfully met
Biocompatibility	Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Found to be non-cytotoxic
	Sensitization (ISO 10993-10)	Non-sensitizing	Found to be non-sensitizing
	Acute Systemic Toxicity (ISO 10993-11)	Non-toxic	Found to be non-toxic
	Irritation (ISO 10993-10)	Non-irritating	Found to be non-irritating
	General Biocompatibility (ISO 10993-1)	Evaluation and testing within a risk management process	Successfully met
Performance (Device Specific)	Intrauterine balloon capacity and diameter test	Performance at least the same as predicate (10cc volume for balloon)	Performed at least the same as predicate (same volume)
	Intrauterine balloon fatigue test (repeat inflation)	Performance at least the same as predicate	Performed at least the same as predicate
	Intrauterine balloon burst test	Performance at least the same as predicate	Performed at least the same as predicate
	Air leakage test for prolonged time	Performance at least the same as predicate	Performed at least the same as predicate
	Spring load locking mechanism force test	Performance at least the same as predicate	Performed at least the same as predicate
	Component joint strength test	Performance at least the same as predicate	Performed at least the same as predicate
	Tip deflection test	Performance at least the same as predicate	Performed at least the same as predicate
	Balloon adhesion strength test	Performance at least the same as predicate	Performed at least the same as predicate
	Luer connector leakage test (ISO 80369-7)	Performance at least the same as predicate; compliant with standard connectors	Performed at least the same as predicate; compliant with standard
	REACH Regulation (EC) No 1907/2006- Non-DEHP (EN 14372:2004)	Non-DEHP	Successfully met

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state specific sample sizes for each individual test. However, it references several standards that typically dictate sample size requirements for testing and quality control:

• ISO 2859-1:1999: "Sampling procedures for inspection by attribute - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection." This standard would have guided the sample sizes for attribute inspection tests.
• ASTM F3172-15: "Design verification device size and sample selection for Endovascular devices." While the DUMI ManipulatOR is not an endovascular device, this standard indicates that sample size selection for design verification was a considered aspect of the testing strategy.

Given the nature of the device (uterine manipulator) and the tests performed (physical, mechanical, biocompatibility, sterilization, packaging), the data would be prospective as the tests were conducted specifically for this submission.

The provenance of the data is not explicitly stated per test but is implied to be from testing labs associated with The O.R. Company Pty Ltd, an Australian company with offices in Australia, North America, and Hong Kong. The testing was conducted to meet international and US FDA standards.

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 tests described are primarily objective, quantitative engineering, microbiological, and chemical tests. Clinical expert "ground truth" (e.g., radiologists, pathologists) is typically relevant for diagnostic devices or AI algorithms that interpret medical data. For a manual surgical instrument, the "ground truth" for performance is established through defined acceptance criteria in engineering standards, material science, and regulatory guidelines.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are usually relevant in clinical trials or studies where human interpretation or consensus is required to establish a gold standard for disease presence or other clinical outcomes. The tests performed for the DUMI ManipulatOR are laboratory-based and objective, with outcomes determined by measurement against predetermined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this device. The DUMI ManipulatOR is a manual surgical instrument, not an AI-powered diagnostic or assistive tool for image interpretation. Therefore, there is no concept of "human readers" or "AI assistance" in its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm-only performance assessment was not done. The DUMI ManipulatOR is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:

• Engineering and Material Standards: Defined specifications and performance limits derived from international and national standards (e.g., ISO, ASTM).
• Predicate Device Equivalence: The performance of the predicate device (Panpac Uterine Manipulator Injector, Model UMI 4.5) serves as a benchmark for comparison in several performance tests. The new device must perform "at least the same as" the predicate.
• Regulatory Requirements: Compliance with quality management systems (ISO 13485, 21 CFR 820), risk management (ISO 14971), and biocompatibility guidelines (ISO 10993 series).

8. The Sample Size for the Training Set:

This information is not applicable. The DUMI ManipulatOR is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The device itself is manufactured, and its performance is verified through testing.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no "training set" for this type of device.

Summary

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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.

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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

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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)

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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 EquivalenceDiscussion:	Indications:The ORC DUMI ManipulatOR and UMI 4.5 have almost identical indications for use. Both devicesare used for diagnostic procedures such as laparoscopy, minilaparotomy, fertility examinations andsalpingoplastic procedures where manipulation of the uterus is required. There is no difference inintended use.Technological characteristics:Both the DUMI ManipulatOR and the UMI 4.5 share almost identical technological characteristics.The designs of both devices consist of a catheter, handle and a balloon to help with manipulationof tissue. The devices have the following differences: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.Performance:As noted in the summary of testing below, the DUMI ManipulatOR was evaluated for performanceand demonstrated to be as safe and effective as the predicate.

Asia Pacific	North America	Hong Kong	Contact
1/32 Silkwood RiseCarrum Downs, VIC3201, Australia	1625 South Tacoma WayTacoma WA, 98409USA	Flat 9/F Wah KitCommercial Centre300 Des Voeux RoadCentral Hong Kong	[e-mail]
T [phone]F [phone]	T [phone]F [phone]	T [phone]F [phone]

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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 MedicalCorporation's Uterine Manipulator Injector (Model UMI 4.5) device. The DUMI ManipulatOR isdemonstrated to be substantial equivalent to the Panpac Medical Corporation's UterineManipulator Injector (Model UMI 4.5) device.
	A series of preclinical physical, mechanical and biocompatibility tests were performed to assessthe safety and effectiveness of The O.R Company Pty Ltd's DUMI ManipulatOR as compared to thepredicate.
	The tests were conducted in accordance with relevant standards listed below and have successfullymet 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,validation & routine control of a sterilization process for medical device
	ISO 11737-1: 2018 Sterilization of Medical devices-Microbiological methods-Part 1: Determinationof a population of microorganisms on products
	ISO 11737-2: 2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests ofsterility performed in the definition, validation and maintenance of a sterilization process
	ISO 11607-1 : 2019 Packaging for terminally sterilized medical devices Part 1: Requirements formaterials, sterile barrier systems and packaging systems
	ISO 11607-2: 2019 Packaging for terminally sterilized medical devices Part 2: Validatio nrequirements 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 dyepenetration.
	ASTM F2096-11 (2019) Standard Test Method For Detecting Gross Leaks In Packaging By InternalPressurization (Bubble Test)
	ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within arisk 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 skinsensitization
	ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicityEN 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 schemesindexed 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: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]

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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 characteristicsas the predicate device. All tests undertaken to demonstrate substantial equivalence of the DUMIManipulatOR meet the requirements of its predetermined acceptance criteria. The test resultsconfirm that the The O.R Company Pty Ltd's DUMI ManipulatOR is as safe and effective as thepredicate device. Therefore, the DUMI ManipulatOR is substantially equivalent to thepredicate.

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Asia Pacific	North America	Hong Kong	Contact
1/32 Silkwood Rise	1625 South Tacoma Way	Flat 9/F Wah KitCommercial 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]

Regulation Number and Section

§ 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.