(197 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML components or data processing beyond basic measurements.
Yes
The device is used for the collection of oocytes, which is a medical procedure aimed at facilitating conception, thus serving a therapeutic purpose (treatment of infertility).
No
The device is designed for the transvaginal collection of oocytes, which is a therapeutic or procedural action, not a diagnostic one. While it uses ultrasonic guidance, the device itself is for collection, not for diagnosing a condition.
No
The device description clearly outlines physical components such as needles, tubing, and a hub, indicating it is a hardware device, not software-only.
Based on the provided information, the Wallace Dual Lumen Oocyte Recovery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of oocytes from ovarian follicles. This is a procedure to obtain a biological sample.
- Device Description: The device is a needle and tubing system designed for aspiration and flushing during a surgical procedure. It is a tool for sample collection, not for analyzing a sample in vitro.
- No mention of analysis: There is no indication that this device is used to perform any tests or analyses on the collected oocytes or any other biological sample outside of the body.
- Performance Studies: The performance studies focus on the physical and biological safety of the device itself (sterilization, biocompatibility, mechanical performance), and the viability of the collected oocytes (Mouse embryo assay), which is a measure of the quality of the collected sample, not a diagnostic test performed by the device.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes. This device's function is to obtain the specimen, not to analyze it.
N/A
Intended Use / Indications for Use
The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
MQE
Device Description
The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.
The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic-guided
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)
Non-Clinical Performance Testing:
- Sterilization testing per ISO 11135:2014
- Ethylene oxide and ethylene chlorohydrin residual testing per ISO 10993-7: 2008 / (R)2012
- Biocompatibility Testing:
- Cytotoxicity per ISO 10993-5: 2009
- Irritation per ISO 10993-10: 2010
- Sensitization per ISO 10993-10: 2010
- Stability and Shelf Life:
- The following tests were completed at baseline and after two-years of accelerated aging per ASTM F1980-16:
- Package integrity testing
- Seal tensile strength per ASTM F88/F88M-15
- Seal peel per ASTM F1886/F1866M-16
- Mouse embryo assay (MEA) - One-cell mouse embryos were incubated in extracts of the subject device and cultured at 37°C. The percent of embryos developed to the expanded blastocyst stage within 96-hours was assessed in comparison to the control group. The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.
- Endotoxin - Evaluation performed using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72-2011 and USP . The acceptance criterion was ≤20 EU/device.
- Mechanical performance testing:
- Joint strength tensile testing
- Needle point penetration force testing
- Needle stiffness
- Tubing flow rate
- Tubing leak testing
- Package integrity testing
- The following tests were completed at baseline and after two-years of accelerated aging per ASTM F1980-16:
- Simulated shipping and distribution testing per ISTA 3A: 2008:
- The following tests were completed after simulated shipping and distribution conditioning:
- Visual inspection
- Bubble leak per ASTM F2096-11
- Mechanical performance testing (see above)
- The following tests were completed after simulated shipping and distribution conditioning:
Key Results: The Wallace Dual Lumen Oocyte Retrieval System passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device. The results demonstrate that the Wallace Dual Lumen Recovery System is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mouse embryo assay (MEA) acceptance criterion: ≥80% embryos expanded to blastocyst at 96 hours.
Endotoxin acceptance criterion: ≤20 EU/device.
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).
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May 10, 2019
CooperSurgical, Inc. Christine Kupchick Regulatory Affairs Associate 95 Corporate Drive Trumbull, CT 06611
Re: K182959
Trade/Device Name: Wallace Dual Lumen Oocyte Recovery System Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MQE Dated: April 10, 2019 Received: April 11, 2019
Dear Christine Kupchick:
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 (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 located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Sharon M. Andrews Assistant Division 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
2
Indications for Use
510(k) Number (if known) K182959
Device Name
Wallace Dual Lumen Oocyte Recovery System
Indications for Use (Describe)
The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
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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Image /page/3/Picture/1 description: The image shows the logo for CooperSurgical. The logo is blue and features the words "CooperSurgical" in a stylized font. Below the company name is the tagline "Healthy women, babies, and families."
510(k) Summary K182959
Submitter Information:
CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611
Contact:
| Name: | Christine Kupchick |
|---|---|
| Telephone: | 203-601-5200 Ext. 3370 |
| Fax: | 203-601-9870 |
| E-mail: | Christine.Kupchick@coopersurgical.com |
Date Prepared: May 9, 2019
Device Identification:
| Trade Name: | Wallace Dual Lumen Oocyte Recovery System |
|---|---|
| Common Name: | Oocyte Retrieval Needle |
| Regulation Number: | 21 CFR 884.6100 |
| Regulation Name: | Assisted Reproduction Needles |
| Product Code: | MQE (Needle, Assisted Reproduction) |
| Regulatory Class: | Class II |
Predicate Device Information
Wallace Dual Lumen Oocyte Retrieval Sets (K031622).
The predicate device has not been subject to a design-related recall.
Device Description
The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.
The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.
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Image /page/4/Picture/1 description: The image is the logo for CooperSurgical. The words "CooperSurgical" are in a blue sans-serif font. Below the company name is the phrase "Healthy women, babies, and families" in a smaller, lighter blue font. The TM symbol is to the right of the word families.
Indications for Use
The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
Substantial Equivalence Discussion
| Table 1: Substantial Equivalence Comparison | |
|---|---|
| Attribute | Wallace Dual Lumen Oocyte
Recovery System - Subject Device | Wallace Dual Lumen Oocyte
Retrieval Sets -
Predicate Device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CooperSurgical, Inc. | Smiths Medical |
| 510(k) Number | K182959 | K031622 |
| Indications for
Use | The Wallace Dual Lumen Oocyte
Recovery System is a sterile, single-
use device for ultrasonic-guided
transvaginal collection of oocytes
from the ovarian follicles. | The Wallace Dual Lumen Oocyte
Retrieval Sets are sterile, single-use
devices for ultrasonic-guided
transvaginal collection of oocytes
from the ovarian follicles. |
| Needle | 33cm dual lumen needle; 17g | 33cm dual lumen needle; 16g and
17g sizes |
| Needle Hub | Molded with friction fit needle
bosses and solvent bonded flushing
side connector | Molded with glued needle bosses
and solvent bonded flushing tube |
| Tubing Sets | Aspiration: 500, 750, and 950mm
Flushing: 700mm
Vacuum: 500mm | Aspiration: 600, 750, and 950mm
Flushing: 600, 750, 950mm
Vacuum: 500mm |
| Device Materials | Stainless steel, methacrylate
butadiene styrene (MBS), silicone,
polyurethane, polycarbonate, Nylon,
and acrylonitrile butadiene styrene
(ABS) | Stainless steel, MBS, silicone,
polyurethane, fluorinated ethylene
propylene (FEP), and ABS |
| Sterilization | Ethylene oxide; SAL 10-6 | Ethylene oxide; SAL 10-6 |
| Number of Uses | Single-use; disposable | Single-use; disposable |
| Shelf Life | Two years | Two years |
The Wallace Dual Lumen Oocyte Recovery System and the predicate device (K031622) have identical Indications for Use statements; therefore, their intended uses are the same.
The subject and predicate device have different technological characteristics. The Wallace Dual Lumen Oocyte Recovery System is a modification of the Wallace Dual Lumen Oocyte Retrieval Sets (K031622). The modifications include:
- Dimensional differences including needle gauges offered and tubing lengths provided.
- Differences in device materials.
- Differences in the design of needle hubs and connectors. ●
The technological differences identified do not raise different questions of safety and effectiveness as compared to the predicate.
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Image /page/5/Picture/1 description: The image contains the logo for CooperSurgical. The logo is blue and features the words "CooperSurgical" in a stylized font. Below the company name is the tagline "Healthy women, babies, and families™".
Non-Clinical Performance Testing
As part of demonstrating substantial equivalence to the predicate, the following tests were performed. The Wallace Dual Lumen Oocyte Retrieval System passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:
- . Sterilization testing per ISO 11135:2014
- . Ethylene oxide and ethylene chlorohydrin residual testing per ISO 10993-7: 2008 / (R)2012
- . Biocompatibility Testing:
- O Cytotoxicity per ISO 10993-5: 2009
- Irritation per ISO 10993-10: 2010 O
- Sensitization per ISO 10993-10: 2010 O
- Stability and Shelf Life ●
- The following tests were completed at baseline and after two-years of accelerated aging O per ASTM F1980-16:
- I Package integrity testing
- . Seal tensile strength per ASTM F88/F88M-15
- . Seal peel per ASTM F1886/F1866M-16
- . Mouse embryo assay (MEA) - One-cell mouse embryos were incubated in extracts of the subject device and cultured at 37°C. The percent of embryos developed to the expanded blastocyst stage within 96-hours was assessed in comparison to the control group. The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.
- l Endotoxin - Evaluation performed using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72-2011 and USP . The acceptance criterion was ≤20 EU/device.
- l Mechanical performance testing:
- Joint strength tensile testing
- Needle point penetration force testing
- Needle stiffness ●
- Tubing flow rate ●
- Tubing leak testing
- I Package integrity testing
- The following tests were completed at baseline and after two-years of accelerated aging O per ASTM F1980-16:
Simulated shipping and distribution testing per ISTA 3A: 2008 ●
- o The following tests were completed after simulated shipping and distribution conditioning:
- l Visual inspection
- Bubble leak per ASTM F2096-11
- l Mechanical performance testing (see above)
6
Image /page/6/Picture/1 description: The image shows the logo for CooperSurgical. The logo is in blue and consists of the words "CooperSurgical" in a stylized font. Below the company name is the tagline "Healthy women, babies, and families" in a smaller font. The tagline also includes the trademark symbol.
Conclusion
The results of the testing described above demonstrate that the Wallace Dual Lumen Recovery System is as safe and effective as the predicate device and supports a determination of substantial equivalence.