(138 days)
Not Found
No
The device description and performance studies focus on mechanical and biological properties, with no mention of AI or ML.
No
The device is intended for aspiration and flushing of oocytes, which is a diagnostic or procedural aid rather than a direct treatment for a disease or condition.
No
The device is intended for flushing and/or aspiration of oocytes from ovarian follicles, which is a procedural or therapeutic action, not a diagnostic one.
No
The device description explicitly lists physical components such as a stainless steel needle, silicone cork, TPE-O tubing, and an adapter, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for flushing and/or aspiration of oocytes from ovarian follicles." This is a procedure performed directly on the patient's body to collect biological material.
- Device Description: The device components (needle, cork, tubing, adapter) are designed for the physical process of aspiration and flushing.
- Lack of Diagnostic Purpose: The device itself does not perform any testing or analysis of the collected oocytes or any other biological sample to provide diagnostic information about a disease or condition. The collected oocytes might be used in subsequent in vitro procedures (like IVF), but the aspiration set itself is not performing the diagnostic step.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device (sterilization, endotoxin, breakage, elasticity, shelf-life, flow, tensile strength), not on the accuracy or reliability of a diagnostic test. The mouse embryo assay is a test of the device's biocompatibility, not a diagnostic test performed by the device.
IVD devices are 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 compatibility purposes. This device is used in vivo (within the body) to collect a specimen.
N/A
Intended Use / Indications for Use
Intended for flushing and/or aspiration of oocytes from ovarian follicles.
Product codes
MOE, MQE
Device Description
The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components:
- A stainless steel needle.
- A silicone cork to be pushed into the opening of a sampling tube.
- A length of TPE-O tubing for aspiration and flushing ●
- An adapter for flushing.
The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound-guided
Anatomical Site
ovarian follicles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
- Sterilization Validation Study per ISO 11137-2:2013 .
- Endotoxin Testing using LAL method per USP to demonstrate that the subject device meets acceptance criterion of ≤1.2 EU/ device
- Breakage and Elasticity Testing to demonstrate that the stainless needle of the subject device meets the requirements in ISO 9626:2016
- Accelerated shelf-life testing to demonstrate that the subject device meets the following ● performance criteria at the end of three-year shelf-life:
- Mouse embryo assay (MEA) - 1-Cell MEA: ≥80% embryos expanded to 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.
- Mouse embryo assay (MEA) - 1-Cell MEA: ≥80% embryos expanded to blastocysts within 96 hours
- Visual Inspection per ASTM F1886/F1886M-09
- Dye Penetration Testing per ASTM F1929-12
- Seal Strength Testing per ASTM F88/F88M-09
- 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
- Tensile Strength Testing - Testing was conducted to assess that tensile strength at joints were within anticipated ranges under intended use conditions
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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November 21, 2017
Vitrolife Sweden AB % Greg Holland Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito Irvine, CA 92606
K172050 Re:
Trade/Device Name: Follicle Aspiration Set, Reduced Single Lumen Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MOE Dated: October 16, 2017 Received: October 19, 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 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.
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.
For comprehensive regulatory information about mediation-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,
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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
Indications for Use
510(k) Number (if known) K172050
Device Name
Follicle Aspiration Set, Reduced Single Lumen
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)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "Vitrolife" in blue font, with a blue swoosh-like design to the right of the word. The font is a serif font, and the word is written in a slightly bolded style. The swoosh design is a simple, curved line that starts thick and tapers to a point.
510(k) Summary - K172050
| 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 |
| Date Prepared | November 17, 2017 |
| Trade Name
Common Name
Classification Name
Regulation Number
Regulatory Class
Product Code | Follicle Aspiration Set, Reduced Single Lumen
Oocyte Retrieval Needle
Assisted Reproduction Needles
884.6100
II
MQE (Needle, Assisted Reproduction) |
| Predicate | Follicle Aspiration Set, Reduced Single Lumen (K082727).
This predicate device has not been subjected to a design-
related recall. |
Device Description:
The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components:
- A stainless steel needle .
- A silicone cork to be pushed into the opening of a sampling tube .
- A length of TPE-O tubing for aspiration and flushing ●
- An adapter for flushing .
The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.
4
| REF | Needle Body [mm] | Needle Tip [mm] | Aspiration Tubing [mm] | ||||||
|---|---|---|---|---|---|---|---|---|---|
| OD | ID | L | OD | ID | L | OD | ID | L | |
| 17175 | 1.4 | 1.2 | 250 | 0.9 | 0.6 | 50 | 2.22 | 1.33 | 600 |
| 17176 | 1.4 | 1.2 | 250 | 0.9 | 0.6 | 50 | 2.22 | 1.33 | 900 |
| 17177 | 1.4 | 1.2 | 300 | 0.9 | 0.6 | 50 | 2.22 | 1.33 | 600 |
| 17178 | 1.4 | 1.2 | 300 | 0.9 | 0.6 | 50 | 2.22 | 1.33 | 900 |
| The cork (REF 21014) has OD of 1.7 mm on the top and 13 mm in the bottom and length of 22 mm. |
Indications 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:
| Devices | K172075 (subject device) | K082727 (predicate device) | ||||
|---|---|---|---|---|---|---|
| Intended use | ||||||
| Indications for Use | Same as predicate | Intended for flushing and/or aspiration | ||||
| of oocytes from ovarian follicles. | ||||||
| Technological characteristics - Design | ||||||
| Lumen type | Same as predicate | Single lumen | ||||
| Needle length | Tip - 50 mm; Body - 250/300 mm | Tip - 40 mm; Body - 260/310 mm | ||||
| Needle Outer Diameter | Same as predicate | Tip - 0.9 mm; Body - 1.4 mm | ||||
| Needle Inner Diameter | Same as predicate | Tip - 0.6 mm; Body - 1.2 mm | ||||
| Aspiration tube length | 600/900 mm | 600 mm | ||||
| Tubing Outer diameter | 2.22 mm | 1.95 mm | ||||
| Tubing Inner diameter | 1.33 mm | 1.35 mm | ||||
| Cannula | Bent cannula on cork | Straight cannula mounted on cork | ||||
| Cork and cannula geometry | Allows connection of a vacuum pump | Requires a connection/cork adapter | ||||
| Technological characteristics - Materials | ||||||
| Aspiration needle | Same as predicate | Stainless steel | ||||
| Needle grip | Same as predicate | Stainless steel | ||||
| Aspiration tubing | Polyolefin based TPE (TPE-0) | Teflon | ||||
| Cork | Same as predicate | Silicone | ||||
| Cork adapter | Acrylonitrile Butadiene Styrene (ABS) Sinkral | Stainless steel | ||||
| Cannula Luer | Methylmethacrylate Acrylonitrile Butadiene | |||||
| Styrene (MABS) | Polypropylene | |||||
| Cannula for flushing | Same as predicate | Stainless steel | ||||
| Protective sheath | Polypropylene | N/A | ||||
| Bonding material | Same as predicate | Epoxy resin |
The subject and predicate devices have the same intended use – flushing and/or aspiration of oocytes from ovarian follicles.
There are differences in design and materials used in different components between the subject and predicate devices. However, these differences do not raise different questions of safety and effectiveness. Similar features are also common in other cleared oocyte retrieval needles.
Performance Testing:
5
The following studies have been performed to support substantial equivalence to the predicate device:
- Sterilization Validation Study per ISO 11137-2:2013 .
- Endotoxin Testing using LAL method per USP to demonstrate that the subject device . meets acceptance criterion of ≤1.2 EU/ device
- Breakage and Elasticity Testing to demonstrate that the stainless needle of the subject . device meets the requirements in ISO 9626:2016
- Accelerated shelf-life testing to demonstrate that the subject device meets the following ● performance criteria at the end of three-year shelf-life:
-
- Mouse embryo assay (MEA) - 1-Cell MEA: ≥80% embryos expanded to 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.
-
- Visual Inspection per ASTM F1886/F1886M-09
-
- Dye Penetration Testing per ASTM F1929-12
-
- Seal Strength Testing per ASTM F88/F88M-09
-
- 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
-
- Tensile Strength Testing - Testing was conducted to assess that tensile strength at joints were within anticipated ranges under intended use conditions
Conclusions
The results of non-clinical performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.