(266 days)
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 Oocyte Retrieval Needle is composed of a stainless steel needle protective sleeve, needle handle, suction catheter, silicone plug, vacuum 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VitaVitro® Oocyte Retrieval Needle.
This document describes a 510(k) premarket notification for a medical device, which typically compares a new device to an existing legally marketed predicate device to demonstrate substantial equivalence. It is important to note that 510(k) submissions generally do not involve clinical trials to prove efficacy against specific clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as the predicate based on technological characteristics and performance testing.
Therefore, many of the questions regarding "study that proves the device meets the acceptance criteria" in a clinical sense, particularly those related to human-in-the-loop performance, effect sizes, and detailed ground truth establishment from patient data, are not typically part of a 510(k) submission for this type of device. The acceptance criteria here are primarily based on non-clinical performance testing demonstrating the device's technical specifications and safety.
1. A table of acceptance criteria and the reported device performance
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic |
| Sensitization (ISO 10993-10:2021) | Non-sensitizing |
| Irritation (ISO 10993-23:2021) | Non-irritating |
| Mouse Embryo Assay (MEA) | |
| ≥80% embryos developed to expanded blastocyst at 96h (per 2021 FDA guidance) | >80% embryos developed to expanded blastocyst at 96h |
| Endotoxin Testing | |
| < 5 EU/device (LAL testing by Gel Clot assay per USP<85>) | < 5 EU/device |
| Sterility Testing | |
| Sterile, ethylene oxide, SAL of 10-6 (ISO 11135:2014) | No microbial growth (meets SAL of 10-6) |
| Residual Ethylene Oxide (ISO 10993-7:2008) | Compliant with ISO 10993-7 |
| Shipping and Package Integrity Testing | |
| Simulated shipping per ASTM D 4169:2016 DC13 | Maintained integrity post-shipping |
| Package integrity per ASTM F88/F88M:2021 (seal peel strength), ASTM F1929:2015 (dye penetration) | Maintained package integrity (meets seal peel strength and dye penetration requirements) |
| Mechanical Performance Testing | |
| Appearance per ISO 7864:2016 | Conforms to appearance standards |
| Dimensional verification | Dimensions verified to specifications |
| Hydraulic resistance per ISO 20695:2020, Annex D | Meets hydraulic resistance requirements |
| Vacuum leakage | No unacceptable vacuum leakage |
| Tensile strength test per ISO 20695:2020, Annex C | Meets tensile strength requirements |
| Flow rate per ISO 20695:2020, Annex E | Meets flow rate specifications |
| Puncture needle test per ISO 9626:2016, Annex B-D (Rigidity, Toughness, Corrosion resistance) | Meets rigidity, toughness, and corrosion resistance standards |
| Needle penetration force per ISO 7864:2016, Annex D | Meets needle penetration force requirements |
| Ultrasound detectability test | Detectable under ultrasound |
| Collection tube compatibility test | Compatible with collection tubes |
| Shelf-life Testing | |
| Maintained product specifications (endotoxin, MEA, sterility, package integrity) over proposed shelf-life (2 years) | Specifications met over the 2-year shelf-life period (initial and aged samples tested for relevant parameters) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text does not provide specific sample sizes for each individual test (e.g., how many devices for sterility, how many mouse embryos for MEA, etc.). It only lists the types of tests performed.
As these are non-clinical (laboratory/bench) tests for a 510(k) submission, the "data provenance" in terms of country of origin or retrospective/prospective human data is not applicable. The tests were performed on the device itself under controlled laboratory conditions, likely at the manufacturer's facility or a contracted testing lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies are non-clinical performance and safety tests, not human-centered clinical studies that require expert-established ground truth. The "ground truth" for these tests are objective, measurable criteria defined by the relevant ISO standards and FDA guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of medical images or patient data is involved to establish a "ground truth" often in cases of disagreement among experts. These performance tests rely on objective laboratory measurements and standardized methodologies.
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
No MRMC comparative effectiveness study was done, nor would it be expected for this type of device (an oocyte retrieval needle) in a 510(k) submission. This is a physical, sterile, single-use medical instrument, not an AI-powered diagnostic tool. The concept of "human readers improve with AI assistance" is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also not applicable. This device is not an algorithm or software. It is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is defined by:
- International Standards (e.g., ISO, ASTM): These standards specify objective, measurable criteria and methodologies acceptable for evaluating medical device performance (e.g., sterility, biocompatibility, mechanical properties).
- FDA Guidance Documents: Specifically mentioned is the 2021 FDA guidance document for Mouse Embryo Assay, which defines the acceptance criteria for MEA performance.
- Device Specifications: The manufacturer's own design specifications for dimensions, flow rate, vacuum maintenance, etc., which are verified through testing.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As there is no training set for this device, this question is not applicable.
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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
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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 OocyteRetrieval 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
| PredicateDevice | 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
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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 |
|---|---|---|---|
| Indicationsfor Use | VitaVitro Single LumenOocyte Retrieval Needle isintended for ultrasoundguided transvaginal aspirationof oocytes from ovarianfollicles for patientsundergoing AssistedReproductive procedures.VitaVitro Double LumenOocyte Retrieval Needle isintended for ultrasoundguided transvaginal aspirationand flushing of oocytes fromovarian follicles for patientsundergoing AssistedReproductive procedures. | The Ovum Pick-Up AspirationNeedles used for aspiration andflushing of oocytes from ovarianfollicles. | Different: Theindications for use forthe subject device andpredicate device are notidentical; however, theyhave the same intendeduse (i.e. aspirationor/and flushing ofoocytes from ovarianfollicles) |
| DesignFeatures | needle, needle protectivesleeve, needle handle,aspiration catheter, siliconeplug, vacuum catheter,flushing catheter and taperjoint. | needle, aspirationline, plug, with or withoutvacuum line, flushing line andtaper joint. | Different |
| Dimension | ORNS-17G, ORNS-18G:Needle: 33 cmAspiration catheter:100 cmVacuum catheter:35 cmNeedle Gauge: 17G or 18GORND-17GNeedle: 35 cmAspiration catheter:100 cmVacuum catheter:35 cmFlushing catheter:100 cmNeedle Gauge: 17G | G44360, G55248, G55252:Needle length:30 cm or 35 cmAspiration line: 60 cm,90 cmNeedle gauge:16G or 17GVacuum line: Not availableG55796, G55798:Needle Gauge: 16G or 17GNeedle Length: 35 cmAspiration Tubing: 75 cmFlushing Tubing: 70 or 100cm Vacuum line: Notavailable | Different |
| Parameter | Subject Device | Predicate Device | Comparison |
| DeviceMaterials | Stainless steel, TPU, siliconePE | Stainless steel,Tetrafluoroethylene(NRT[TFE]) | Different |
| Needle type | Single Lumen OvumAspiration Needles andDouble Lumen OvumAspiration Needles | Single Lumen OvumAspiration Needles andDouble Lumen OvumAspiration Needles | Same |
| Endotoxin | < 5EU/device | Not publicly available | Different |
| MEA | ≥80% embryos developed toexpanded blastocyst at 96h | Not publicly available | Different |
| Sterile | No microbial growth | No microbial growth | Same |
| Single Use | Yes | Yes | Same |
| Shelf life | 2 years | Not publicly available | Different |
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The subject and predicate device have the same intended use - to transvaginally aspirate oocytes from ovarian follicles with the aid of ultrasound imaging. In addition, as shown in the table above, there are technological differences between the subject and predicate device, including the device components, device dimensions, materials used, performance testing, and shelf-life. However, these differences do not raise different questions of safety and effectiveness.
8. Summary of Non-Clinical Performance
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-
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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: < 5EU/device, LAL testing by Gel Clot assay per USP<85>
- . 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.
§ 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).