(253 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI, ML, or data processing for decision-making or analysis.
No.
The device is used for manipulation of the uterus and injection of fluids, which are procedural aids rather than direct therapeutic treatments.
No
The device is described as a uterine manipulator injector used during medical procedures for physical manipulation of the uterus or injection of fluids, not for diagnosing a condition or disease. While it is indicated for use in "Diagnostic Laparoscopy" procedures, its function within that procedure is manipulative/interventional, not diagnostic.
No
The device description clearly outlines a physical, sterile, single-use product made of plastic with lumens, a balloon, a handle, and other physical components. The performance studies also focus on physical characteristics and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "manipulation of the uterus" and "injection of fluids into the uterine lumen" during various medical procedures. This is a physical manipulation and delivery of substances within the body.
- Device Description: The description details a physical device with a tube, balloon, handle, and lumens for inflation and injection. This is consistent with a surgical or procedural instrument, not a device that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on physical manipulation and fluid delivery within the uterus during a medical procedure.
N/A
Intended Use / 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.
Product codes
LKF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Sterilization validation testing:
- ISO 11135-1:2014
- ISO 10993-7: 2008
- Package integrity testing:
- Visual inspection per ASTM F1886/F1886M-16
- Seal Strength testing per ASTM F88/ F88M-23
- Dye Penetration test per ASTM F1929-15
- 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
- Irritation per ISO 10993-23: 2021
- Acute Systemic Toxicity per ISO 10993-11:2017
- Material Mediated Pyrogenicity Testing per USP
- Key Results: Testing showed the device material to be non-cytotoxic, non-sensitizing, non-irritating, non-systemically 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
- Bend test (Force to tip deflection)
- Cuff Burst Test
- Tensile strength testing (all joints/connections)
- Repeated cuff inflation
- Prolonged inflation
- Insertion depth marker integrity testing
- Handle locking mechanism testing to determine force needed to move the handle from its set position.
- Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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
2
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
3
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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4
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:
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.
5
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 | Subject
RELIEEV" Uterine
Manipulator Injector | Predicate
Panpac Uterine Manipulator
Injector, Model Umi 4.5
(K092980) | Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | CUMI 5.0 | UMI 4.5K | NA |
| 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. | This Uterine Manipulator Injector
(Model UMI-4.5) is indicated for
use in Diagnostic Laparotomy,
Minilaparotonny, Fertility
Examinations, and Salpingoplastic
procedures where manipulation of
the uterus is required. This product
also facilitates the sealing of
cervical os while providing a fluid
injection port. | The Indications for Use
statements of the subject and
predicate devices are not
identical. However, the
intended uses are the same (i.e.,
for use in medical procedures
where manipulation of the
uterus is needed and for
delivering fluid to the uterine
lumen). |
| Prescription
Medical 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 With
Natural Rubber
Latex | Yes | Yes | Same |
| Device Lumens | 2
(1 inflation channel and 1
media channel) | 2
(1 inflation channel and 1 media
channel) | Same |
| Shape | The shape of handle and rigid
tube are curved.
The handle can be adjustable
for physician use. | The shape of handle and rigid tube
are curved.
The handle can be adjustable for
physician use. | Same |
| Insertion Depth
Indicator | Laser engraving | Not publicly available | Different: Differences in
insertion depth markers do not
raise different questions of
safety and effectiveness (S&E). |
| Pilot Balloon | Yes | Not publicly available | Different: Differences in the
inclusion of a pilot balloon to
assess cuff inflation
maintenance does not raise
different questions of S&E. |
| | | | |
| Balloon Inflation
Volume | 10cc | Not publicly available | Different: Differences in
balloon inflation volume do not
raise different questions of
S&E. |
| Materials | PVC - Rigid Tube, Balloon
(Cuff), HUB-3 Way, HUB-2
Way, Pilot Balloon, Inflation
Valve, Leur Lock
POM and Stainless Steel -
Handle
TPU – Cuff Inflation Line
PP - 10 mL syringe
UV Acrylic Adhesive | Not publicly available | Different: Differences in
device materials do not raise
different questions of S&E. |
| Dimensions | Total Length - 360.0 mm | Not publicly available | Different: Differences in
device dimensions do not raise
different questions of S&E. |
| | Curved Tube Length: 335.0
mm | Not publicly available | |
| | Curved Tube Diameter: 5 mm | Not publicly available | |
| | Balloon Length: 33.5 mm | Not publicly available | |
| | Balloon (Cuff) Outer Diameter
10 mL – 23.0-24.9 mm | Not publicly available | |
| | Handle Length - 220.0 mm | Not publicly available | |
6
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
7
- 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
-
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.