(331 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the aspiration sets, with no mention of AI or ML capabilities.
No.
The device is intended for flushing and/or aspiration of oocytes from ovarian follicles, which is a diagnostic or procedural function, not a therapeutic one that directly treats a disease or health condition.
No
This device is intended for flushing and aspiration, which are physical procedures, not for identifying a disease or condition. While it uses ultrasound for guidance, the device itself does not provide diagnostic information.
No
The device description clearly outlines physical components made of materials like stainless steel, TPE-O tubing, silicone, etc., and the performance studies include testing of these physical components (e.g., mechanical testing of needles, tensile strength testing).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for flushing and/or aspiration of oocytes from ovarian follicles." This describes a procedure performed on the patient's body to collect biological material.
- Device Description: The device is a set of needles and tubing designed for physically accessing and extracting oocytes. It's a surgical/procedural tool.
- Lack of Diagnostic Function: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. This device does not perform any analysis or provide diagnostic information about the collected oocytes or the patient's condition. It is solely for the collection of the sample.
While the collected oocytes might be used in subsequent in vitro procedures (like IVF), the aspiration set itself is a tool for the in vivo collection of those oocytes.
N/A
Intended Use / Indications for Use
Intended for flushing and/or aspiration of oocytes from ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
MOE (Needle, Assisted Reproduction)
Device Description
Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below.
The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene.
Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
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)
- Sterilization Validation per ISO 11137-2:2013.
- Endotoxin testing (USP, LAL) - 80% expanded blastocysts within 96 hours. One-cell mouse embryos were exposed to subject device extracts and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group.
- Vacuum Testing – Assessment of device function under vacuum pressure at -500 mmHg. Devices were shown to operate as intended without signs of damage.
- Flow Testing - Testing was conducted to assess that flow rates were within anticipated ranges under intended use conditions.
- Mechanical Testing of Needles - Breakage, Bend, Stiffness per ISO 9626: 2016.
- Tensile Strength Testing
- Biocompatibility Testing: Cytotoxicity testing per 10993-5:2009; Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010; Intracutaneous Reactivity testing per ISO 10993-10:2010. Testing showed that the device extracts assessed were non-cytotoxic, non-sensitizing, and non-irritating.
- Shelf-life studies (accelerated) were conducted to ensure that the following acceptance criteria are met for the for devices over their 3 years shelf-life: 1-cell MEA >=80% expanded blastocysts within 96 hours; Standard Test Method for Seal Strength of Flexible Barrier Materials per ASTM F88 / F88M - 09; Dye Penetration per ASTM F1929 12; Visual Inspection per ASTM F1886 / F1886M 09; Tensile Strength Testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in a dark color, possibly black or a dark shade of blue.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
Vitrolife Sweden AB % Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606
Re: K161970 Trade/Device Name: Follicle Aspiration Set Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MOE Dated: April 28, 2017 Received: May 1, 2017
Dear Greg Holland:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161970
Device Name Follicle Aspiration Set
Indications for Use (Describe) Intended for flushing and/or aspiration of oocytes from ovarian follicles
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary – K161970
| Submitter | Vitrolife Sweden AB Gustaf Werners gata 2 SE - 421 32 Västra Frölunda SWEDEN Nina Arvidsson TEL: (46) 31 721 80 00 FAX: (46) 31 721 80 99 |
|---|---|
| Contact Person | Greg Holland Regulatory Consultant to Vitrolife Sweden AB Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: 949.422.3853 FAX: 949.552.2821 EMAIL: greg@regulatoryspecialists.com |
| Summary Date | June 14, 2017 |
| Trade Name | Follicle Aspiration Set (See the Device Description section below for device versions included in this submission) |
| Common Name | Oocyte Retrieval Needle |
| Classification Name | Assisted Reproduction Needles |
| Regulation Number | 884.6100 |
| Class | II |
| Panel | Obstetrics/Gynecology |
| Product Code | MQE (Needle, Assisted Reproduction) |
| Predicate Device | K991273, Swemed Follicle Aspiration Set, Double Lumen Swemed Follicle Aspiration Set, Single Lumen Swemed Follicle Aspiration Luer Needle |
The predicate device has not been subjected to a recall.
4
Device Description:
Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below.
The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene.
Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures. The table below shows the specific features of the different versions of this device:
| REF | Needle | Tubing | ||||
|---|---|---|---|---|---|---|
| OD [mm] | ID [mm] | Length [mm] | OD [mm] | ID [mm] | Length [mm] | |
| 17103 | 1.4 | 1.0 | 300 | 2.22 | 1.33 | 400 |
| 17107 | 1.4 | 1.0 | 300 | 2.22 | 1.33 | 600 |
| 17112 | 1.4 | 1.0 | 300 | 2.22 | 1.33 | 900 |
| 17125 | 1.4 | 1.0 | 330 | 2.22 | 1.33 | 900 |
| 17132 | 1.4 | 1.0 | 350 | 2.22 | 1.33 | 600/600 |
| 17156 | 1.4 | 1.0 | 350 | 2.22 | 1.33 | 600 |
| 17130 | 1.4 | 1.0 | 350 | 2.22 | 1.33 | 900 |
| 17119 | 1.6 | 1.1 | 250 | 2.32 | 1.53 | 600 |
| 17126 | 1.6 | 1.1 | 250 | 2.32 | 1.53 | 900 |
| 17113 | 1.6 | 1.1 | 300 | 2.32 | 1.53 | 400 |
| 17116 | 1.6 | 1.1 | 300 | 2.32 | 1.53 | 600 |
| 17120 | 1.6 | 1.1 | 300 | 2.32 | 1.53 | 900 |
| 17145 | 1.6 | 1.1 | 350 | 2.32 | 1.53 | 400 |
| 17157 | 1.6 | 1.1 | 350 | 2.32 | 1.53 | 600 |
| 17104 | 1.6 | 1.1 | 350 | 2.32 | 1.53 | 900 |
| 17183* | 1.4 | 1.0 | 350 | 2.22 | 1.33 | 750 |
| 17185 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 600 |
| 17186 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 900 |
*This version of the device does not include echogenic markings.
Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization
5
| REF | Needle | Tubing | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Outer | Inner | Aspiration tube | Flush tube | Vacuum tube | |||||||||||
| OD [mm] | ID [mm] | L [mm] | OD [mm] | ID [mm] | L [mm] | OD [mm] | ID [mm] | L [mm] | OD [mm] | ID [mm] | L [mm] | OD [mm] | ID [mm] | L [mm] | |
| 17151 | 1.5 | 1.3 | 350 | 1.1 | 0.90 | 400 | 2.32 | 1.43 | 600 | 2.22 | 1.33 | 600 | - | - | - |
| 17102 | 1.5 | 1.3 | 350 | 1.1 | 0.90 | 400 | 2.32 | 1.43 | 1000 | 2.22 | 1.33 | 1000 | - | - | - |
| 17150 | 1.65 | 1.45 | 250 | 1.2 | 1.0 | 300 | 2.32 | 1.43 | 400 | 2.22 | 1.33 | 400 | - | - | - |
| 17105 | 1.65 | 1.45 | 300 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 900 | 2.22 | 1.33 | 900 | - | - | - |
| 17108 | 1.65 | 1.45 | 300 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 400 | 2.22 | 1.33 | 400 | - | - | - |
| 17131 | 1.65 | 1.45 | 300 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 400 | 2.22 | 1.33 | 900 | - | - | - |
| 17158 | 1.65 | 1.45 | 300 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 600 | 2.22 | 1.33 | 400 | - | - | - |
| 17111 | 1.65 | 1.45 | 300 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 600 | 2.22 | 1.33 | 600 | - | - | - |
| 17129 | 1.65 | 1.45 | 300 | 1.2 | 1.0 | 350 | 2.32 | 1.43 | 900 | 2.22 | 1.33 | 900 | 2.32 | 1.43 | 900 |
| 17161 | 1.65 | 1.45 | 350 | 1.2 | 1.0 | 400 | 2.32 | 1.43 | 400 | 2.22 | 1.33 | 400 | - | - | - |
| 17109 | 1.65 | 1.45 | 350 | 1.2 | 1.0 | 400 | 2.32 | 1.43 | 600 | 2.22 | 1.33 | 600 | - | - | - |
| 17148 | 1.65 | 1.45 | 350 | 1.2 | 1.0 | 400 | 2.32 | 1.43 | 900 | 2.22 | 1.33 | 600 | - | - | - |
| 17114 | 1.65 | 1.45 | 350 | 1.2 | 1.0 | 400 | 2.32 | 1.43 | 900 | 2.22 | 1.33 | 900 | - | - | - |
| 17168 | 1.65 | 1.45 | 350 | 1.2 | 1.0 | 400 | 2.32 | 1.43 | 1000 | 2.22 | 1.33 | 1000 | - | - | - |
during aspiration procedures. The table below shows the specific features of the different versions of this device:
Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures. The table below shows the specific features of this device:
| REF | Needle | Tubing | ||||
|---|---|---|---|---|---|---|
| OD [mm] | ID [mm] | Length [mm] | OD [mm] | ID [mm] | Length [mm] | |
| 17123 | 1.5 | 1.2 | 300 | 2.32 | 1.43 | 600 |
Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures. The table below shows the specific features of the different versions of this device:
| Dimension | |||
|---|---|---|---|
| REF | OD [mm] | ID [mm] | Length [mm] |
| 17154 | 1.2 | 0.8 | 300 |
| 17152 | 1.4 | 1.2 | 250 |
| 17140 | 1.4 | 1.2 | 300 |
| 17147 | 1.6 | 1.3 | 300 |
| 17137 | 1.6 | 1.3 | 350 |
6
Indication for Use:
Intended for flushing and/or aspiration of oocytes from ovarian follicles.
Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices:
| Device & Predicate Device(s): | K161970 | K991273 |
|---|---|---|
| General Device Characteristics | ||
| Indication for use | Intended for flushing | |
| and/or aspiration of | ||
| oocytes from ovarian | ||
| follicles | The swemed follicle aspiration | |
| set, double lumen, swemed | ||
| follicle aspiration set, single | ||
| lumen, and swemed follicle | ||
| aspiration luer needle and | ||
| intended to obtain gametes | ||
| from the body are specially | ||
| indicated for flushing and/or | ||
| aspiration of oocytes from | ||
| ovarian follicles. | ||
| Materials | ||
| Aspiration needle | Stainless steel | Stainless steel |
| Needle grip | Stainless steel | Stainless steel |
| Aspiration tubing | Polyolefin based | |
| TPE (TPE-0) | Teflon | |
| Cork | Silicone | Silicone |
| Cork adapter | Bent blunt cannula | |
| mounted on the cork | ||
| Adapter/ blunt | ||
| cannula is not | ||
| needed for a syringe | ||
| with luer slip. | ||
| Syringe with luer | ||
| lock - new adapter is | ||
| needed to be able to | ||
| connect to the cork | Straight Blunt Stainless steel | |
| cannula (can be used to connect | ||
| a vacuum pump) | ||
| An adapter (a blunt cannula) is | ||
| always needed to be able to | ||
| connect a syringe to the cork. | ||
| Cannula Luer | Methyl Methacrylate | |
| Acrylonitrile | ||
| Butadiene Styrene | Polypropylene luer lock | |
| connection | ||
| Cannula for flushing | Stainless steel | Stainless steel |
| Protective sheath | Polypropylene | Not provided |
7
| Bonding | Epoxy resin | Epoxy resin |
|---|---|---|
| Packaging | Tyvek+ | |
| Polyethlene/ | ||
| Polypropylene (clear | ||
| transparent) | Paper + | |
| Polyethlene/Polypropylene | ||
| (green transparent) | ||
| Sterility | Radiation | Steam |
| Mouse Embryo Assay (MEA) | 1-Cell MEA: ≥ 80 % | |
| expanded blastocysts | ||
| within 96 hours. | 2-Cell MEA | |
| Endotoxins | 80% expanded blastocyst within 96 hours using the one-cell MEA, while the predicate device conducted a two-cell MEA. Both methods are acceptable to support ART devices and do not raise different questions of safety or effectiveness. |
Performance Testing:
The following studies have been performed to support substantial equivalence to the predicate device:
- Sterilization Validation per ISO 11137-2:2013.
- . Endotoxin testing (USP, LAL) - ≤1.2 EU/ device
- . Mouse embryo assay (MEA) – 1-Cell MEA: >80% expanded blastocysts within 96 hours
One-cell mouse embryos were exposed to subject device extracts and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group.
- . Vacuum Testing – Assessment of device function under vacuum pressure at -500 mmHg. Devices were shown to operate as intended without signs of damage.
- Flow Testing - Testing was conducted to assess that flow rates were within anticipated ranges under intended use conditions.
10
- . Mechanical Testing of Needles
- Breakage, Bend, Stiffness per ISO 9626: 2016. o
- Tensile Strength Testing
- . Biocompatibility Testing:
- Cytotoxicity testing per 10993-5:2009 o
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 O
- o Intracutaneous Reactivity testing per ISO 10993-10:2010
Testing showed that the device extracts assessed were non-cytotoxic, non-sensitizing, and non-irritating.
- . Shelf-life studies (accelerated) were conducted to ensure that the following acceptance criteria are met for the for devices over their 3 years shelf-life:
- 1-cell MEA ≥80% expanded blastocysts within 96 hours O
- Standard Test Method for Seal Strength of Flexible Barrier Materials per O ASTM F88 / F88M - 09
- Dye Penetration per ASTM F1929 12 о
- Visual Inspection per ASTM F1886 / F1886M 09 о
- Tensile Strength Testing o
Conclusions from Non-Clinical Performance Data
The results of the performance testing described above demonstrate that the Follicle Aspiration Set is as safe and effective as the predicate device and supports a determination of substantial equivalence.