(253 days)
Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.
The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.
This document is an FDA 510(k) summary for the "RELIEEV" Uterine Manipulator Injector. It describes the device and claims substantial equivalence to a predicate device, the Panpac Uterine Manipulator Injector, Model Umi 4.5 (K092980).
Based on the provided text, the device in question is a medical instrument, not an AI/software device. Therefore, the questions related to AI/software performance, ground truth, human readers, and training/test sets are not applicable to this document.
The acceptance criteria and study proving the device meets them are related to the physical and biological safety and performance of the Uterine Manipulator Injector, rather than an AI algorithm.
Here's the information extracted from the document, tailored to the type of device described:
Acceptance Criteria and Device Performance for "RELIEEV" Uterine Manipulator Injector
This device is a physical medical instrument, and its performance evaluation focuses on its physical characteristics, sterility, biocompatibility, and mechanical integrity, comparing it to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document details various tests performed to ensure the device meets safety and performance standards for a physical medical device. The "acceptance criteria" are implied by the successful completion of these tests per the referenced standards and the statement that "all predetermined acceptance criteria were met."
| Area of Performance | Specific Test/Evaluation | Acceptance Criteria (Implied by standard and successful outcome) | Reported Device Performance |
|---|---|---|---|
| Sterilization | EO sterilization validation | Conformance to ISO 11135-1:2014 & ISO 10993-7:2008 for residual EtO | Met (testing performed) |
| Packaging | Visual inspection | Conformance to ASTM F1886/F1886M-16 | Met (testing performed) |
| Seal Strength testing | Conformance to ASTM F88/F88M-23 | Met (testing performed) | |
| Dye Penetration test | Conformance to ASTM F1929-15 | Met (testing performed) | |
| Transportation | Transportation Simulation testing | Conformance to ASTM D4169-23 | Met (testing performed) |
| Biocompatibility | Cytotoxicity | Non-cytotoxic per ISO 10993-5:2009 | Non-cytotoxic |
| Sensitization | Non-sensitizing per ISO 10993-10:2021 | Non-sensitizing | |
| Irritation | Non-irritating per ISO 10993-23:2021 | Non-irritating | |
| Acute Systemic Toxicity | Non-systemically toxic per ISO 10993-11:2017 | Non-systemically toxic | |
| Material Mediated Pyrogenicity | Non-pyrogenic per USP | Non-pyrogenic | |
| Bench Performance (after accelerated aging) | Dimensional specifications | Met pre-determined criteria | All "predetermined acceptance criteria were met" |
| Bend test (Force to tip deflection) | Met pre-determined criteria | All "predetermined acceptance criteria were met" | |
| Cuff Burst Test | Met pre-determined criteria | All "predetermined acceptance criteria were met" | |
| Tensile strength testing (all joints/connections) | Met pre-determined criteria | All "predetermined acceptance criteria were met" | |
| Repeated cuff inflation | Met pre-determined criteria | All "predetermined acceptance criteria were met" | |
| Prolonged inflation | Met pre-determined criteria | All "predetermined acceptance criteria were met" | |
| Insertion depth marker integrity testing | Met pre-determined criteria | All "predetermined acceptance criteria were met" | |
| Handle locking mechanism testing (force to move from set position) | Met pre-determined criteria | All "predetermined acceptance criteria were met" |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for the various tests. It refers to established testing standards (e.g., ISO, ASTM, USP), which would specify appropriate sample sizes for each test type. The data provenance is from bench testing and laboratory evaluations conducted by the manufacturer (LI Medical Corporation LTD.) to support regulatory submission. This is a prospective assessment of newly manufactured devices under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not applicable to the assessment of a physical medical device like a uterine manipulator. "Ground truth" in this context refers to the defined acceptable parameters for physical and biological performance, which are established by international standards and regulatory guidelines, not by individual experts evaluating images or clinical data.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device. Performance is judged against specified engineering, material, and biological safety standards, not through adjudication of expert opinions.
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
Not applicable, as this is not an AI/software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an AI/software device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards and regulatory requirements for medical device safety and efficacy. This includes:
- Physical and mechanical properties (e.g., dimensions, tensile strength, inflation capabilities).
- Sterility assurance (e.g., EtO residuals).
- Biocompatibility (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
- Packaging integrity.
These are quantitative metrics or pass/fail criteria derived from validated test methods.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/software device. There is no "training set" in the context of a physical medical device's performance validation; rather, there are samples tested according to predefined standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/software 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.