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.

Device Description

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.

AI/ML Overview

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 <151>	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.

Summary

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October 16, 2024

LI Medical Corporation Ltd. Chen Jago CEO 2F., No. 43, Zhongxing Rd. Xizhi District, New Taipei City 221012 TAIWAN

Re: K240364

Trade/Device Name: "RELIEEV" Uterine Manipulator Injector Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 14, 2024 Received: September 16, 2024

Dear Chen Jago:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Michael T. Bailey -S

for

Monica D. Garcia, 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) K240364

Device Name "RELIEEV" Uterine Manipulator Injector

Indications for Use (Describe)

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.

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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510(k) Summary - K240364

"RELIEEV" Uterine Manipulator Injector

I. Submitter Information

Company Name:	LI Medical Corporation LTD.
Company Address:	2F., No. 43, Zhongxing Rd., Xizhi Dist.,New Taipei City 221012, Taiwan
Telephone:	+886-2-86461999
Contact Person:	Jago Chen, CEO
Email:	jago.chen@li-med.com.tw
Date Prepared:	October 10, 2024

II. Device Information:

Trade Name:	"RELIEEV" Uterine Manipulator Injector
Common Name:	Uterine Manipulator Injector
Regulation Name:	Obstetric-gynecologic specialized manual instrument
Regulation Number:	884.4530
Regulatory Class:	II
Product Code:	LKF (Cannula, Manipulator/Injector, Uterine)

III. Predicate Device Information:

Panpac Uterine Manipulator Injector, Model Umi 4.5 (K092980), manufactured by Panpac Medical Corporation. The predicate device has not been subject to a design-related recall

IV. Device Description:

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V. Indications for Use:

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.

VI. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Device

A comparison of the intended use and technological characteristics of the subject and predicate device are included in the table below.

Attribute	SubjectRELIEEV" UterineManipulator Injector	PredicatePanpac Uterine ManipulatorInjector, Model Umi 4.5(K092980)	Comparison
Model	CUMI 5.0	UMI 4.5K	NA
Indications for Use	Use of the "RELIEEV"Uterine Manipulator Injector isindicated in DiagnosticLaparoscopy, Minilaparotomy,Fertility Exams, andSalpingoplasty procedureswhere manipulation of theuterus is required.	This Uterine Manipulator Injector(Model UMI-4.5) is indicated foruse in Diagnostic Laparotomy,Minilaparotonny, FertilityExaminations, and Salpingoplasticprocedures where manipulation ofthe uterus is required. This productalso facilitates the sealing ofcervical os while providing a fluidinjection port.	The Indications for Usestatements of the subject andpredicate devices are notidentical. However, theintended uses are the same (i.e.,for use in medical procedureswhere manipulation of theuterus is needed and fordelivering fluid to the uterinelumen).
PrescriptionMedical Device	Yes	Yes	Same
Single Patient Use	Yes	Yes	Same
Sterile Device	Yes; EO sterilization	Yes; EO sterilization	Same
Shelf life	3 years	3 years	Same
Not Made WithNatural RubberLatex	Yes	Yes	Same
Device Lumens	2(1 inflation channel and 1media channel)	2(1 inflation channel and 1 mediachannel)	Same
Shape	The shape of handle and rigidtube are curved.The handle can be adjustablefor physician use.	The shape of handle and rigid tubeare curved.The handle can be adjustable forphysician use.	Same
Insertion DepthIndicator	Laser engraving	Not publicly available	Different: Differences ininsertion depth markers do notraise different questions ofsafety and effectiveness (S&E).
Pilot Balloon	Yes	Not publicly available	Different: Differences in theinclusion of a pilot balloon toassess cuff inflationmaintenance does not raisedifferent questions of S&E.

Balloon InflationVolume	10cc	Not publicly available	Different: Differences inballoon inflation volume do notraise different questions ofS&E.
Materials	PVC - Rigid Tube, Balloon(Cuff), HUB-3 Way, HUB-2Way, Pilot Balloon, InflationValve, Leur LockPOM and Stainless Steel -HandleTPU – Cuff Inflation LinePP - 10 mL syringeUV Acrylic Adhesive	Not publicly available	Different: Differences indevice materials do not raisedifferent questions of S&E.
Dimensions	Total Length - 360.0 mm	Not publicly available	Different: Differences indevice dimensions do not raisedifferent questions of S&E.
	Curved Tube Length: 335.0mm	Not publicly available
	Curved Tube Diameter: 5 mm	Not publicly available
	Balloon Length: 33.5 mm	Not publicly available
	Balloon (Cuff) Outer Diameter10 mL – 23.0-24.9 mm	Not publicly available
	Handle Length - 220.0 mm	Not publicly available

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As shown in the table above, there are differences in the indications for use statements that do not represent a new intended use. In addition, there are technological differences between the subject and predicate device (e.g., device materials, dimensions, depth markers, etc.). However, the technological differences noted in the table do not raise different questions of safety and effectiveness.

VII. Performance Data

The following studies have been performed to support of the substantial equivalence to the predicate device:

Sterilization validation testing: ●
- ISO 11135-1:2014
- A ISO 10993-7: 2008
. Package integrity testing:
- Visual inspection per ASTM F1886/F1886M-16 A
- A Seal Strength testing per ASTM F88/ F88M-23
- A Dye Penetration test per ASTM F1929-15

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Transportation Simulation testing per ASTM D4169-23
. Biocompatibility studies conducted in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included the following assessments:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization ISO 10993-10: 2021
- A Irritation per ISO 10993-23: 2021
- A Acute Systemic Toxicity per ISO 10993-11:2017
- Material Mediated Pyrogenicity Testing per USP <151>

Testing showed the device material to be non-cytotoxic, non-sensitizing, non-irritating, nonsystemically toxic and non-pyrogenic.

Bench performance studies before and after accelerated aging to the equivalent of three-years of real-time aging in accordance with ASTM F1980-21 demonstrated that all predetermined acceptance criteria were met in the following tests:
- Dimensional specifications A
- Bend test (Force to tip deflection) A
- A Cuff Burst Test
- A Tensile strength testing (all joints/connections)
- A Repeated cuff inflation
- A Prolonged inflation
- Insertion depth marker integrity testing
- Handle locking mechanism testing to determine force needed to move the handle from its > set position.

VIII. Conclusion

The results of the testing described above demonstrate that the "RELIEEV" Uterine Manipulator Injector is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.