(216 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the needle and tubing, with no mention of AI or ML for image analysis, data processing, or any other function.
No.
The device is used to retrieve oocytes, which is a diagnostic/procedural step in Assisted Reproductive procedures, not a treatment for a disease or condition itself.
No
Explanation: The device is used for the aspiration and flushing of oocytes, which is an interventional procedure not for diagnostic purposes.
No
The device description clearly details physical components such as stainless steel needles, handles, tubes, stoppers, and connectors, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Lotus Single and Double Lumen Ovum Aspiration Needles are used to collect biological material (oocytes) from the body. They are not used to perform a diagnostic test on that material. The subsequent procedures involving the collected oocytes (Assisted Reproductive procedures) might involve IVD components or processes, but the needle itself is a tool for retrieval.
- Lack of Diagnostic Testing: The device description and intended use clearly state its purpose is for aspiration and flushing of oocytes. There is no mention of any testing or analysis being performed by the device itself on the collected oocytes.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device (biocompatibility, sterility, mechanical performance, embryo toxicity), not on the accuracy or reliability of a diagnostic test.
In summary, the Lotus Ovum Aspiration Needle is a medical device used for a procedural step (oocyte retrieval) within a broader medical process (Assisted Reproductive procedures). It does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Product codes (comma separated list FDA assigned to the subject device)
MQE
Device Description
The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles.
The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length.
The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ovarian follicles
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)
The following non-clinical performance tests were performed:
Biocompatibility: Testing included Cytotoxicity (ISO 10993-5:2009/R 2014), Sensitization (ISO 10993-10:2010/R 2014), and Intracutaneous Irritation (ISO 10993-23:2021). The results showed the devices are non-cytotoxic, non-irritating, and non-sensitizing.
Sterilization Testing: The devices are subjected to an Ethylene Oxide (EO) sterilization process to achieve a Sterility Assurance Level (SAL) of 106, validated per the half-cycle method in accordance with ISO 11135:2014. Ethylene oxide and ethylene chlorohydrin residual testing was conducted per ISO 10993-7: 2008/(R)2012.
Simulated Transportation: Performed after accelerated aging per ASTM D4169-22.
Stability and Shelf Life: Tests were completed to demonstrate performance in newly manufactured devices and after 3-years of accelerated aging per ASTM F1980-16 and simulated transportation.
- Mouse embryo assay (MEA) Testing: Conducted in accordance with the 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices." Acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours after 30 minute exposure.
- Endotoxin: Evaluation performed using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72:2011 and USP . Acceptance criterion was ≤ 20 EU/device.
- Package Integrity Testing: Included F1886/F1886M-16, ASTM F88/F88-15, and ASTM F1929-15.
- Mechanical Performance Testing: Included Appearance, Dimensional verification/validation, Needle stiffness, breakage resistance, and corrosion resistance per ISO 9626:2016, Tip penetration force, needle bond strength, and flow rate per ISO 7864:2016, Ultrasound detectability, Tubing bond strength, leak, and aspiration test per EN1618, and Component compatibility (connectors and stoppers).
Key results: The results of the performance testing demonstrate that the subject devices are as safe and effective as the predicate device and support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
1-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours after a 30 minute exposure to the Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle.
Endotoxin:
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
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 rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2024
Zhejiang Horizon Medical Technology Co., Ltd. Wu Tang RA Supervisor Room 219, 2nd floor, Building 9, 1303 Asia-Pacific Road Daqiao Town, Nanhu District Jiaxing, Zhejiang 314006 CHINA
Re: K232163
Trade/Device Name: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MQE Received: January 24, 2024
Dear Wu Tang:
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.
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
2
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-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) K232163
Device Name
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
Indications for Use (Describe)
Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
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 K232163
1. Submitter Information
| Applicant: | Zhejiang Horizon Medical Technology Co., Ltd. |
|---|---|
| Address: | Room 219, 2nd floor, Building 9, 1303 Asia- |
| Pacific Road, Daqiao Town, Nanhu District, | |
| Jiaxing City, Zhejiang Province, P. R. China. |
2. Submission Correspondent
| Company: | Zhejiang Horizon Medical Technology Co., Ltd. |
|---|---|
| Contact: | Tang Wu |
| Phone: | +86-21-38954600-59403 |
| Email: | wu.tang@microport.com |
3. Date prepared: February 20, 2024
4. Device Information
| Device Name: | Lotus Single Lumen Ovum Aspiration Needle;
Lotus Double Lumen Ovum Aspiration Needle |
|--------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Assisted Reproduction Needles |
| Regulation Number: | 21 CFR 884.6100 |
| Regulation Name: | Assisted Reproduction Needles |
| Product Code: | MQE (Needle, Assisted Reproduction) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | Wallace Dual Lumen Oocyte Recovery System |
|---|---|
| 510(k) Number: | K191291 |
| Sponsor: | CooperSurgical Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles.
The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single
5
Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length.
The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.
7. Indications for Use Statement
Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| K232163 | K191291 | Comparison | |
|---|---|---|---|
| Manufacturer | Zhejiang Horizon | ||
| Medical Technology | |||
| Co., | CooperSurgical | -- | |
| Classification | Class II | Class II | Same |
| Product Code | MQE | MQE | Same |
| Regulation | 21 CFR 884.6100 | 21 CFR 884.6100 | Same |
| Indications for Use | Lotus Single Lumen | ||
| Ovum Aspiration | |||
| Needle is used for | |||
| ultrasound guided | |||
| transvaginal aspiration | |||
| of oocytes from ovarian | |||
| follicles for patients | |||
| undergoing Assisted | |||
| Reproductive | |||
| procedures. | |||
| Lotus Double Lumen | |||
| Ovum Aspiration | |||
| Needle is used for | |||
| ultrasound guided | The Wallace Dual | ||
| Lumen Oocyte | |||
| Recovery System is | |||
| a sterile, single-use | |||
| device for | |||
| ultrasonic-guided | |||
| transvaginal | |||
| collection of | |||
| oocytes from the | |||
| ovarian follicles. | There are differences | ||
| between the subject and | |||
| predicate device | |||
| indications for use | |||
| statements; however, the | |||
| subject and predicate | |||
| devices have the same | |||
| intended use (i.e., to | |||
| recover oocytes from | |||
| ovarian follicles for use in | |||
| assisted reproduction | |||
| procedures). | |||
| transvaginal aspiration | |||
| and flushing of oocytes | |||
| from ovarian follicles | |||
| for patients undergoing | |||
| Assisted Reproductive | |||
| procedures. | |||
| Lumen Type | Single and Double | Double | Different |
| Materials | Single - Stainless steel | ||
| (304), FEP, PC, Silicone | |||
| Double - Stainless steel | |||
| (304), FEP, PC, | |||
| Silicone, HDPE | Stainless steel, | ||
| methacrylate | |||
| butadiene styrene | |||
| (MBS), silicone, | |||
| polyurethane, | |||
| polycarbonate, | |||
| Nylon, acrylonitrile | |||
| butadiene, styrene | |||
| (ABS) | Different | ||
| Needle Gauge | Single - 16G to 21G | ||
| Double – 17G | 16G to 17G | Different | |
| Needle Length | Single - 350 mm | ||
| Double - 300 mm to 350 | |||
| mm | 330 mm | Different | |
| Echogenic Markers | Yes | Yes | Same |
| Aspiration Tubing | |||
| Length | Single - 600 mm to 900 | ||
| mm | |||
| Double - 900 mm | 500 mm, 750 mm, | ||
| 950 mm | Different | ||
| Flushing Tubing | |||
| Length | 700 and 1000 mm | 700 mm | Different |
| Fitting | Single - Silicone stopper | ||
| with vacuum tubing | |||
| terminating in a leur | |||
| vacuum pump | |||
| connector. | |||
| Double - Silicone | |||
| stopper attached to leur | |||
| vacuum connector for | |||
| vacuum tubing | |||
| connection. | Silicone bung that | ||
| allows connection | |||
| to sample tube. | |||
| Bung is connected | |||
| to vacuum tubing | |||
| that allows | |||
| connection to a | |||
| vacuum source | Different | ||
| Sterilization Method | EO | EO | Same |
| Single/Repeat Use | Single Use | Single Use | Same |
| MEA | 1-Cell MEA: ≥ 80% | ||
| embryos developed to | |||
| expanded blastocyst at | |||
| 96 hours after a 30 | |||
| minute exposure to the | 1-Cell MEA: ≥ 80% | ||
| embryos developed | |||
| to expanded | |||
| blastocyst at 96 | |||
| hours. | Different | ||
| Lotus Single Lumen | |||
| Ovum Aspiration | |||
| Needle; Lotus Double | |||
| Lumen Ovum | |||
| Aspiration Needle. | |||
| Endotoxin | . The acceptance criterion was ≤ 20 EU/device. |
- Package Integrity Testing: ●
- F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible O Packaging by Visual Inspection
- ASTM F88/F88-15 Standard Test Method for Seal Strength of Flexible Barrier Materials o
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks In Porous Medical O Packaging by Dye Penetration
- Mechanical Performance Testing: ●
- Appearance O
- Dimensional verification/validation O
- Needle stiffness, breakage resistance, and corrosion resistance per ISO 9626:2016 O
- Tip penetration force, needle bond strength, and flow rate per ISO 7864:2016 O
- Ultrasound detectability O
- Tubing bond strength, leak, and aspiration test per EN1618 O
- Component compatibility (connectors and stoppers) O
10. Conclusion
The results of the performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and support a determination of substantial equivalence.