(224 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts.
Yes.
The device is used for aspiration and flushing of oocytes for patients undergoing Assisted Reproductive procedures, which is a therapeutic intervention.
No
This device is used for the aspiration and flushing of oocytes, which is a therapeutic or procedural function, not a diagnostic one. While it uses ultrasound for visualization, the device itself does not provide diagnostic information.
No
The device description clearly outlines physical components such as a stainless-steel needle, tubing, stopper, and test tube, and the performance studies include mechanical and biocompatibility testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical aspiration and flushing of oocytes from ovarian follicles. This is a surgical/procedural device used to collect biological material.
- Device Description: The description details a needle, tubing, stopper, and collection tube. These are all components of a device used for a physical procedure, not for analyzing a sample in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the collected oocytes or any other biological sample to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device itself (biocompatibility, mechanical performance, stability), and the effect of device extracts on mouse embryos (to ensure it doesn't harm the collected oocytes). These are not studies evaluating the diagnostic accuracy of the device.
IVD devices are typically used to examine specimens such as blood, urine, or tissue samples in vitro to provide information for diagnosis, monitoring, or screening. This device is used to collect a specimen for a procedure (Assisted Reproductive Procedures), not to perform a diagnostic test on that specimen.
N/A
Intended Use / Indications for Use
The Single Lumen Ovum Aspiration Needles are used for laparoscopic or 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)
MOE, MQE
Device Description
Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.
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
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)
To support the modifications to the subject device, the following design verification and validation activities were performed and summarized:
- Biocompatibility per ISO 10993-1:2009
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Irritation (ISO 10993-10:2010)
- Mouse Embryo Assay (Two cell mouse embryos were exposed to device extracts and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocysts stage within 72 hours were assessed in comparison with the control group. The acceptance criteria for this test is ≥80% development to blastocyst at 72 hours.)
- Endotoxin testing per USP (
§ 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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January 12, 2018
Willian A. Cook Australia Pty. Ltd. Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains, Queensland 4113 Australia
Re: K171625
Trade/Device Name: Single Lumen Ovum Aspiration Needles Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MOE Dated: December 12, 2017 Received: December 15, 2017
Dear Gordana Pozvek:
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,
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Single Lumen Ovum Aspiration Needles
Indications for Use (Describe)
The Single Lumen Ovum Aspiration Needles are used for laparoscopic or 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K171625 Page 1 of 4
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WILLIAM A. COOK AUSTRALIA PTY. LTD. BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA HONE: 1800.777.222 FAX: +61.7.3841 WWW.COOKMEDICA
510(k) Summary - K171625
SUBMITTED BY:
William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains OLD 4113 Australia
| Contact Person: | Gordana Pozvek Ph.D. |
|---|---|
| Tel: | +61 (7) 3841 1188 |
| Fax: | +61 (7) 3841 3905 |
| E-mail: | Gordana.Pozvek@CookMedical.com |
Date Prepared: January 11, 2018
DEVICE IDENTIFICATION:
| Trade Name: | Single Lumen Ovum Aspiration Needles |
|---|---|
| Common Name: | Oocyte Retrieval Needles |
| Regulation No: | 21 CFR 884.6100, Assisted Reproduction Needle |
| Regulatory Class: | II |
| Product Code: | MQE - Needle, Assisted Reproduction |
PREDICATE DEVICE:
Ovum Pick-Up Aspiration Needles (K983593)
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION:
Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound.
4
The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.
| Product
codes | Needle
gauge | Needle
length
(cm) | Aspiration
Line (cm) | Vacuum
Line (cm) | Flushing
Line
(cm) | Bevel
Type |
|-------------------|--------------------------|--------------------------|-------------------------|---------------------|--------------------------|---------------|
| K-OPAA-
series | 17, 18, 20 | 35 | n/a | n/a | n/a | B |
| K-DOPU-
series | 17 | 28 or 35 | 60 or 90 | n/a | n/a | B |
| K-OPS-
series | 16, 17, 19,
20, or 21 | 28, 30, 33,
or 35 | 60 or 90 | n/a | n/a | A or B |
| K-OSN-
series | 16 or 17 | 25, 30, 33,
or 35 | 60 or 90 | 50 | n/a | A or B |
| K-IOPS-
series | 20 | 35 | 60 | 50 | n/a | A |
| K-UCI-
series | 16 or 17 | 30 or 35 | 60 | n/a | 60 | A |
The following needle series are included in this 510(k):
INDICATIONS FOR USE:
The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Single Lumen Ovum Aspiration Needles have similar Indications for Use as the predicate device (K983593). The intended use of the subject device is the same as the predicate device.
The Single Lumen Ovum Aspiration Needles are a modification of the Ovum Pick-up Aspiration Needles (K983593). The modifications are:
- The indications for use statement has been modified from the predicate device to include transvaginal ultrasound and laparoscopic approaches, both of which were specifically stated within cleared labeling for the legally marketed device. This modification to the Indication for Use statement does not impact safety and effectiveness of the device.
- Addition of a 21-gauge variant to the K-OPS Series needles. This modification provides a smaller gauge needle option. The 21-gauge variant has a 4 Fr aspiration tubing.
5
- Addition of a 17 gauge, 30 cm guide needle. This modification provides a guide needle size suitable for the 20-gauge K-IOPS variant.
- The aspiration and flushing tubing has changed from Tetrafluoroethylene (NRT [TFE]) to Fluorinated Ethylene Propylene (NRT-FEP) and Polytetrafluoroethylene (NRT-PTFE).
The modifications listed above do not raise different questions of safety and effectiveness as compared to the predicate device.
PERFORMANCE DATA:
To support the modifications to the subject device, the following design verification and validation activities were performed and summarized:
- Biocompatibility per ISO 10993-1:2009 ●
- o Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) o
- o Irritation (ISO 10993-10:2010)
- Mouse Embryo Assay Two cell mouse embryos were exposed to device extracts ● and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocysts stage within 72 hours were assessed in comparison with the control group. The acceptance criteria for this test is ≥80% development to blastocyst at 72 hours.
- Endotoxin testing per USP (