(154 days)
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.
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.
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.
§ 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.