(224 days)
The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).
This document describes the premarket notification (510(k)) for the "RELIEEV" Suction Curette. The information provided in the document does not contain details about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, as the device is a physical medical instrument, not a software or AI-based product.
The document discusses performance data related to physical bench testing, biocompatibility, packaging and shipping validation, sterilization validation, and shelf life to demonstrate substantial equivalence to a predicate device.
To address your request, I will categorize the information presented in the document as it pertains to the performance and validation of this physical device.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific numerical acceptance criteria values are generally not explicitly stated for each test, but rather the conclusion that the device "passed" or "performed according to product specifications" is given. The "Reported Device Performance" here reflects these summarized outcomes.
| Acceptance Criteria Category (Implied/General) | Reported Device Performance (Summary from document) |
|---|---|
| Bench Testing | |
| Dimensional Analysis Performance | Performed according to product specifications (passed) |
| Suction Force Performance | Performed according to product specifications (passed) |
| Marker Readability after Bending Performance | Performed according to product specifications (passed) |
| Bending Force Performance | Performed according to product specifications (passed) |
| Biocompatibility Testing | |
| Cytotoxicity | Non-cytotoxic (Passed ISO 10993-5:2009) |
| Sensitization | Non-sensitizer (Passed ISO 10993-10:2021) |
| Irritation | Non-irritant (Passed ISO 10993-23:2021) |
| Packaging and Shipping Validation | |
| Withstand distribution environment | Withstood distribution environment (Passed ASTM D4332-22 & ASTM D4169-22) |
| Seal Peel Test | Passing results (per ASTM F88/F88M-23) |
| Dye Penetration | Passing results (per ASTM F1929-15) |
| Visual Inspection | Passing results (per ASTM F1886/F1886M-16) |
| Sterilization Validation | |
| Sterility Assurance | Sterilization process validated per ISO 11135:2014; sterility testing and documentation provided. |
| Shelf Life | |
| 3-year Shelf Life Claim | Supported by accelerated aging (ASTM F1980-21) and package integrity/bench testing on aged devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the individual tests (e.g., number of devices tested for suction force, biocompatibility, etc.). It only states that "Physical bench testing was performed" and "The subject device test results were compared with the predicate device".
Data Provenance: The manufacturing company is LI Medical Corporation LTD. in New Taipei City, Taiwan. The studies were likely conducted either internally by the manufacturer or by contract testing laboratories performing the specified ISO and ASTM standards. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the "RELIEEV" Suction Curette as described in the document. This is a physical medical device, not a diagnostic device involving expert interpretation of data or images to establish a "ground truth" for a test set. The validation relies on objective physical, chemical, and biological testing standards.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments, which are not detailed in this document for the provided device. The device validation relies on standardized tests with defined pass/fail criteria.
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
This question is not applicable. An MRMC study is relevant for diagnostic devices that involve human readers interacting with images or data, often in the context of AI assistance. The "RELIEEV" Suction Curette is a physical instrument for tissue sampling.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is not an algorithm or software. It is a physical suction curette.
7. The type of ground truth used
This question is not directly applicable in the terms usually associated with AI/ML devices. For this physical device, "ground truth" is established through:
- Physical measurements and functional performance standards: Defined by product specifications and comparing against the predicate device.
- Standardized testing methods: Such as ISO and ASTM standards for biocompatibility, sterility, packaging, and shelf-life, which provide objective criteria for success or failure.
- Analytical chemistry and microbiology results: For biocompatibility and sterility.
8. The sample size for the training set
This question is not applicable. There is no AI/ML component described for this device, therefore no "training set" in that context. The device is validated through traditional engineering, biological, and sterility testing.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for an AI/ML algorithm for this physical device.
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September 25, 2024
LI Medical Corporation Ltd. Jago Chen CEO 2F., No. 43, Zhongxing Rd. New Taipei City, Xizhi Dist. 221012 TAIWAN
Re: K240434
Trade/Device Name: "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial Suction Curette and accessories Regulatory Class: II Product Code: HHK Received: August 30, 2024
Dear Jago Chen:
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" (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).
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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 Rule"). 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.
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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-regulatory-
assistance/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,
Reginald K. Avery -S
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K240434
Device Name
"RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6)
Indications for Use (Describe)
The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
| 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
510(K) Number: K240434
I. SUBMITTER
LI Medical Corporation LTD. 2F., No. 43, Zhongxing Rd., Xizhi Dist., New Taipei City 221012, Taiwan Phone: +886-2-86461999 Fax: +886-2-26471999 Contact Person: Jago Chen, CEO Email: jago.chen@li-med.com.tw Date Prepared: Sep. 24, 2024
II. DEVICE
| Device Name : | "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) |
|---|---|
| Trade/Proprietary Name : | RELIEEV |
| Common Name : | Endometrial suction curette |
| Regulation Number : | 21 CFR 884.1175 |
| Regulation Name : | Endometrial suction curette and accessories |
| Regulatory Class : | Class II |
| Product Code : | HHK |
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PREDICATE DEVICES REFERENCED IN THE SUBMISSION lll.
| Predicate Device : | The PANPAC SUCTION CURETTE |
|---|---|
| Company Name : | PANPAC |
| 510(k) number: | K092982 |
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).
V. INDICATIONS FOR USE
The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
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VII. COMPARISON TO PREDICATE DEVICES
| Subject Device (K240434) | Predicate Device (K092982) | ||
|---|---|---|---|
| Manufacture | LI Medical Corporation LTD. | PANPAC Medical Corporation | COMPARISON |
| Device name | "RELIEEV" Suction Curette (Flexible 3.0/Standard 3.6) | The PANPAC Suction Curette | |
| Model | Model 1: ESC30A1 (Flexible 3.0)Model 2: ESC36A1 (Standard 3.6) | The Preferred Curette(Standard 3.0- Model M0014) | |
| Common name | Endometrial Suction Curette | Endometrial Suction Curette | Same |
| Regulation number | 21 CFR 884.1175 | 21 CFR 884.1175 | Same |
| Product code | HHK | HHK | Same |
| Classification | Class II | Class II | Same |
| Prescription medicaldevice | Yes | Yes | Same |
| Single patient use | Yes | Yes | Same |
| Sterile device | Yes | Yes | Same |
| Disposable device | Yes | Yes | Same |
| Sterilization method | Ethylene Oxide (EtO) | EtO | Same |
| Hole on the tube | YES(1 hole on the side of the tube) | YES(1 hole on the side of the tube) | Same |
| Indications for Use | The "RELIEEV" Suction Curette (Flexible3.0/ Standard 3.6) is used to removesamples of materials from the uterus andfrom the mucosal lining of the uterus by | An endometrial suction curette,such as the curette and preferredcurette (available in 2.5 and 3.0mm outer diameters) are devices | Same |
| scraping or vacuum suction. These devicesobtain tissue samples for purposes ofbiopsy precancer screening or they can beused for menstrual extraction. | used to remove samples ofmaterials from the uterus andfrom the mucosal lining of theuterus by scraping or vacuumsuction. These devices obtaintissue samples for purposes ofbiopsy precancer screening orthey can be used for menstrualextraction. | ||
| Length | Flexible 3.0PP tube: $240.0 \pm 3.0$ mmPiston: $264.0 \pm 3.0$ mmStandard 3.6PP tube: $240.0 \pm 3.0$ mmPiston: $264.0 \pm 3.0$ mm | M0014(Model M0014) Curette Length-240 mm | Same |
| Dimensions | Flexible 3.0PP tube O.D: $3.0 + 0.10/-0.03$ mmPiston cover with O-ring O.D.: $2.7 \pm 0.05$ mmStandard 3.6PP tube O.D: $3.6 +0.10/-0.03$ mmPiston cover with O-ring O.D.: $2.7 \pm 0.05$ mm | M0014PP tube O.D: 3.0 mmPiston O.D: 2.2 mm | Different |
| Material | Flexible 3.0 and Standard 3.6Tube: Polypropylene | M0014Tube: Polypropylene | Different |
| Piston: PolypropyleneO-ring: Silicone (Purple pigment) | Piston: PolypropyleneO-ring: Silicone (blue color) | ||
| Scale marked on thetube | Laser engraving | Ink printed | Different |
| Packaging | Medical paper grade pouch (60g) | Tyvek pouch | Different |
| Shelf life | 3 years | 3 years | Same |
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LI Medical Corporation LTD. 510(k): K240434
The subject and predicate device differ in the dimensions, materials, scale marking and packaging. These technological differences do not raise different questions of safety and effectiveness and are addressed with performance testing.
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PERFORMANCE DATA VIII.
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Physical bench testing was performed to confirm that the device performs according to the product specifications. Device evaluation consisted of physical and functional testing including:
- Dimensional Analysis,
- Suction Force,
- Marker readability after bending, and
- Bending Force
The subject device test results were compared with the predicate device and passed all functional bench testing.
Biocompatibility Testing
The biocompatibility testing was conducted in accordance with the 2023 FDA guidance document, Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The "RELIEEV" Suction Curette is considered mucosal tissue contacting for less than 24 hours and the testing included the following tests with passing results.
| Test name | Results | Standards |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | ISO 10993-5:2009 |
| Sensitization | Non-sensitizer | ISO 10993-10:2021 |
| Irritation | Non-irritant | ISO 10993-23:2021 |
Packaging and Shipping Validation
Packaging and shipping validation were conducted on the subject device in order to confirm that the packaging materials are capable of withstanding the distribution environment during the rigors of shipping and handling.
For the simulated shipping distribution testing the environmental conditions were selected in accordance with ASTM D4332-22 and then the simulated shipping distribution was conducted per ASTM D4169-22, DC 13.
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Packaging integrity testing consisting of seal peel test per ASTM F88/F88M-23, dye penetration per ASTM F1929-15, and visual inspection per ASTM F1886/F1886M-16 were completed with passing results.
Sterilization validation
The subject device is sterilized via ethylene oxide. Sterilization validation was conducted as per ISO 11135:2014 Sterilization of health-care products – Ethylene oxide requirement for the development, validation, and routine control of a sterilization process for medical devices. Sterility testing and documentation were provided as outlined in the 2024 FDA guidance document, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Shelf Life
Shelf life testing was performed to support a shelf life of 3 years. Accelerated aging was conducted as per ASTM F1980-21 and package integrity testing for seal integrity and seal strength was completed using the methods under ASTM F1929-15. Bench testing, as described above, were completed on aged devices to support device functionality after aging. The results of these tests support the 3-year shelf-life claim.
CONCLUSIONS IX.
Subject and predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design between the subject and predicate devices do not raise different questions of safety and effectiveness. The results of performance testing demonstrate that the subject device is as safe and effective as the predicate devices to support a substantial equivalence determination.
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).