(266 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a needle, with no mention of software, algorithms, or data processing related to AI/ML.
No
The device is an oocyte retrieval needle used for aspiration and/or flushing of oocytes in Assisted Reproductive Procedures, which is a diagnostic/interventional procedure, not a therapeutic treatment itself.
No
This device is designed for the aspiration and flushing of oocytes, which is a therapeutic/interventional procedure for Assisted Reproductive Technology, not a diagnostic one. While it uses ultrasound for guidance, the device itself doesn't provide a diagnosis.
No
The device description clearly outlines multiple physical components made of materials like stainless steel and silicone, and the performance studies include mechanical testing and biocompatibility evaluations, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the physical retrieval of oocytes from ovarian follicles using ultrasound guidance. This is a surgical/procedural device, not a device used to perform tests on biological samples in vitro (outside the body).
- Device Description: The description details a needle and associated components for aspiration and flushing. This aligns with a surgical instrument, not an IVD.
- Performance Studies: The performance studies focus on biocompatibility, sterility, mechanical performance, and shelf-life. These are typical tests for a medical device that interacts with the body, not for an IVD which would focus on analytical performance (accuracy, precision, etc.) of a test.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or the analysis of biological samples for diagnostic purposes.
While the retrieved oocytes might be used in subsequent in vitro procedures (like fertilization), the needle itself is the tool for the in vivo retrieval process.
N/A
Intended Use / Indications for Use
VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures. VitaVitro Double Lumen Oocyte Retrieval Needle is intended 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 Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter, flushing catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. This product is a disposable, sterile medical device, sterilized by ethylene oxide.
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
Patients undergoing Assisted Reproductive procedures.
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 studies have been performed for the device to support the substantial equivalence to the predicate device 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. "
- Biocompatibility evaluation
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2021)
- Irritation (ISO 10993-23:2021)
Testing results demonstrate that the subject devices are non-cytotoxic, non-irritating, and non-sensitizing.
- 1-cell MEA per the 2021 FDA guidance document Mouse Embryo Assay for Assisted Reproduction Technology Devices: >80% embryos developed to expanded blastocyst at 96h
- Endotoxin testing:
- Sterility testing
- Sterile, ethylene oxide, SAL of 10-6 (ISO 11135:2014)
- Residual testing (ISO 10993-7:2008)
- Shipping and package integrity testing
- Simulated shipping per ASTM D 4169:2016 DC13
- Package integrity per ASTM F88/F88M:2021 (seal peel strength), ASTM F1929:2015 (dye penetration)
- Mechanical performance testing
- Appearance per ISO 7864:2016
- Dimensional verification
- Hydraulic resistance per ISO 20695:2020, Annex D
- -Vacuum leakage
- -Tensile strength test per ISO 20695:2020, Annex C
- -Flow rate per ISO 20695:2020, Annex E
- -Puncture needle test per ISO 9626:2016, Annex B-D: Rigidity test, Toughness test, Corrosion resistance
- Needle penetration force per ISO 7864:2016, Annex D ---
- Ultrasound detectability test
- Collection tube compatibility test
- Shelf-life testing was conducted to ensure that product specifications for endotoxin, MEA, sterility, and package integrity were met over the proposed shelf-life period.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Endotoxin: =80% embryos developed to expanded blastocyst at 96h
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
§ 884.6100 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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2024
Donghai Pan Official Applicant R601, Building B, Hai Ke Xing Tech Park Baoshan Road No. 16 Shenzhen, Guangdong 518118 CHINA
Re: K240523
Trade/Device Name: VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G): VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MQE Received: October 15, 2024
Dear Donghai Pan:
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/cdrb/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.
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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).
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 QS 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.
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
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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,
Monica D. Garcia -S
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
Submission Number (if known)
Device Name
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G) VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
Indications for Use (Describe)
VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
VitaVitro Double Lumen Oocyte Retrieval Needle is intended 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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510(k) SUMMARY - K240523
1. Submission Sponsor
Shenzhen VitaVitro Biotech Co., Ltd. R601, Building B, Hai Ke Xing Tech Park Baoshan Road No. 16 Shenzhen 518118 Guangdong, China Contact Person: Mr. Donghai Pan Title: International Regulatory Specialist Tel: 86-755-84511813 Fax: 86-755-85235226
Email: pandh(@vitavitro.com
2. Date Prepared
November 14, 2024
3. Device Identification
| Trade/Device Name: | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-
17G, ORNS-18G); VitaVitro® Double Lumen Oocyte
Retrieval Needle (ORND-17G) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Oocyte Retrieval Needle |
| Regulation Number: | 21 CFR § 884.6100 |
| Regulation Name: | Assisted Reproduction Needles |
| Device Classification: | Class II |
| Product Code: | MQE (Needle, Assisted Reproduction) |
4. Predicate Device
| Predicate
| Device | Trade Name | Ovum Pick-Up Aspiration Needle |
|---|---|---|
| Manufacturer | Cook OB/GYN | |
| 510(k) No. | K983593 | |
| Regulatory Class | Class II | |
| Product Code | MQE |
The predicate device has not been subject to any design-related recalls.
5. Device Description
The Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum catheter, flushing catheter and taper joint. The device includes both dual lumen (ORND) and single-lumen needles (ORNS). Three models are available: ORNS-17G, ORNS-18G and ORND-17G. The oocyte retrieval needles are available in 17 or 18 gauge sizes and two lengths: 33 and 35 cm. The needles are provided with a suction catheter of 100 cm length and a vacuum
5
catheter with a length of 35 cm, and the ORND-17G also includes a flushing catheter of 100 cm length. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound.
This product is a disposable, sterile medical device, sterilized by ethylene oxide.
6. Indications For Use
VitaVitro Single Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
VitaVitro Double Lumen Oocyte Retrieval Needle is intended for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
7. Substantial Equivalence Discussion
The tables below list the comparisons of the indications for use and technological characteristics of the subject and predicate devices.
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| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Indications | |||
| for Use | VitaVitro Single Lumen | ||
| Oocyte Retrieval Needle is | |||
| intended for ultrasound | |||
| guided transvaginal aspiration | |||
| of oocytes from ovarian | |||
| follicles for patients | |||
| undergoing Assisted | |||
| Reproductive procedures. | |||
| VitaVitro Double Lumen | |||
| Oocyte Retrieval Needle is | |||
| intended for ultrasound | |||
| guided transvaginal aspiration | |||
| and flushing of oocytes from | |||
| ovarian follicles for patients | |||
| undergoing Assisted | |||
| Reproductive procedures. | The Ovum Pick-Up Aspiration | ||
| Needles used for aspiration and | |||
| flushing of oocytes from ovarian | |||
| follicles. | Different: The | ||
| indications for use for | |||
| the subject device and | |||
| predicate device are not | |||
| identical; however, they | |||
| have the same intended | |||
| use (i.e. aspiration | |||
| or/and flushing of | |||
| oocytes from ovarian | |||
| follicles) | |||
| Design | |||
| Features | needle, needle protective | ||
| sleeve, needle handle, | |||
| aspiration catheter, silicone | |||
| plug, vacuum catheter, | |||
| flushing catheter and taper | |||
| joint. | needle, aspiration | ||
| line, plug, with or without | |||
| vacuum line, flushing line and | |||
| taper joint. | Different | ||
| Dimension | ORNS-17G, ORNS-18G: | ||
| Needle: 33 cm | |||
| Aspiration catheter:100 cm | |||
| Vacuum catheter:35 cm | |||
| Needle Gauge: 17G or 18G | |||
| ORND-17G | |||
| Needle: 35 cm | |||
| Aspiration catheter:100 cm | |||
| Vacuum catheter:35 cm | |||
| Flushing catheter:100 cm | |||
| Needle Gauge: 17G | G44360, G55248, G55252: | ||
| Needle length:30 cm or 35 cm | |||
| Aspiration line: 60 cm,90 cm | |||
| Needle gauge:16G or 17G | |||
| Vacuum line: Not available | |||
| G55796, G55798: | |||
| Needle Gauge: 16G or 17G | |||
| Needle Length: 35 cm | |||
| Aspiration Tubing: 75 cm | |||
| Flushing Tubing: 70 or 100 | |||
| cm Vacuum line: Not | |||
| available | Different | ||
| Parameter | Subject Device | Predicate Device | Comparison |
| Device | |||
| Materials | Stainless steel, TPU, silicone | ||
| PE | Stainless steel, | ||
| Tetrafluoroethylene | |||
| (NRT[TFE]) | Different | ||
| Needle type | Single Lumen Ovum | ||
| Aspiration Needles and | |||
| Double Lumen Ovum | |||
| Aspiration Needles | Single Lumen Ovum | ||
| Aspiration Needles and | |||
| Double Lumen Ovum | |||
| Aspiration Needles | Same | ||
| Endotoxin | 80% embryos developed to expanded blastocyst at 96h |
- . Endotoxin testing:
- . Sterility testing
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Sterile, ethylene oxide, SAL of 10-6 (ISO 11135:2014)
- Residual testing (ISO 10993-7:2008) |
- . Shipping and package integrity testing
- Simulated shipping per ASTM D 4169:2016 DC13
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Package integrity per ASTM F88/F88M:2021 (seal peel strength), ASTM F1929:2015 (dye penetration)
- . Mechanical performance testing
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Appearance per ISO 7864:2016
- Dimensional verification |
- Hydraulic resistance per ISO 20695:2020, Annex D
- -Vacuum leakage
- -Tensile strength test per ISO 20695:2020, Annex C
- -Flow rate per ISO 20695:2020, Annex E
- -Puncture needle test per ISO 9626:2016, Annex B-D: Rigidity test, Toughness test, Corrosion resistance
- Needle penetration force per ISO 7864:2016, Annex D ---
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Ultrasound detectability test
- Collection tube compatibility test
- Shelf-life testing was conducted to ensure that product specifications for endotoxin, MEA, ●
sterility, and package integrity were met over the proposed shelf-life period.
9. 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.