(138 days)
Intended for flushing and/or aspiration of oocytes from ovarian follicles.
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.
The provided text is a 510(k) summary for the Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen. This document demonstrates the device's substantial equivalence to a predicate device, rather than providing a detailed study report for meeting specific performance criteria typically associated with AI/ML-enabled devices.
Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and submission. This is a medical device clearance based on engineering performance and material compatibility, not on diagnostic accuracy derived from AI analysis of data.
However, I can extract the acceptance criteria and reported performance for the engineering and biological tests conducted.
Acceptance Criteria and Device Performance for Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Validation | Met ISO 11137-2:2013 standards. (Specific performance metric not detailed, but implied compliance). |
| Endotoxin Testing | ≤ 1.2 EU/device (determined by LAL method per USP <85>). |
| Breakage and Elasticity Testing | Met requirements in ISO 9626:2016 for stainless steel needle. (Specific performance metric not detailed, but implied compliance). |
| Accelerated Shelf-Life Testing (3-year shelf-life): | |
| - Mouse Embryo Assay (MEA): ≥ 80% embryos expanded to blastocysts within 96 hours. | One-cell mouse embryos exposed to device extracts. Percent of embryos developed to expanded blastocyst stage within 96 hours were assessed in comparison with the control group. (Specific percentage not detailed, but implied compliance indicating ≥ 80% was achieved or demonstrated equivalence to control). |
| - Visual Inspection | Performed per ASTM F1886/F1886M-09. (Specific results not detailed, but implied compliance). |
| - Dye Penetration Testing | Performed per ASTM F1929-12. (Specific results not detailed, but implied compliance). |
| - Seal Strength Testing | Performed per ASTM F88/F88M-09. (Specific results not detailed, but implied compliance). |
| - Vacuum Testing: Operate as intended without damage under -500 mmHg vacuum pressure. | Demonstrated operation as intended without signs of damage. |
| - Flow Testing: Flow rates within anticipated ranges under intended use conditions. | Demonstrated flow rates within anticipated ranges. |
| - Tensile Strength Testing: Tensile strength at joints within anticipated ranges. | Demonstrated tensile strength at joints within anticipated ranges. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test set (e.g., number of devices for endotoxin testing, number of embryos for MEA). The tests are typically laboratory-based engineering and biological assessments compliant with recognized standards. Data provenance is not described in terms of geographical origin or retrospective/prospective study design as would be relevant for clinical data. These are intrinsic performance tests of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for these types of tests is generally defined by the specific test method, instrument calibration, and adherence to international standards (e.g., ISO, ASTM, USP). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for these performance evaluations. Qualified laboratory personnel perform and interpret the results according to the established protocols.
4. Adjudication Method for the Test Set
Not applicable. These are quantitative and qualitative laboratory tests with defined pass/fail criteria from international standards. There is no ambiguous "case" interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an aspiration set, primarily a mechanical and sterile instrument, not an imaging or diagnostic device that involves human interpretation of results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI-enabled system. Its performance is entirely mechanical, material-based, and biological compatibility.
7. The Type of Ground Truth Used
The ground truth is based on established international and national standards and methodologies for medical device performance, sterility, material safety, and biocompatibility. Examples include:
- Sterilization: ISO 11137-2:2013
- Endotoxin: USP <85>
- Needle Properties: ISO 9626:2016
- Embryo Toxicity: Mouse Embryo Assay (MEA), a recognized biological test.
- Packaging Integrity: ASTM F1886/F1886M-09, ASTM F1929-12, ASTM F88/F88M-09
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is irrelevant to the device submission.
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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.
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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,
Image /page/1/Picture/6 description: The image shows the text "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The letters are clear and easy to read. The text appears to be a name, followed by an initial.
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
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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510(k) Summary - K172050
| Submitter | Vitrolife Sweden ABGustaf Werners gata 2SE - 421 32 Västra FrölundaSWEDENNina ArvidssonTEL: (46) 31 721 80 00FAX: (46) 31 721 80 99 |
|---|---|
| Contact Person | Greg HollandRegulatory Consultant to Vitrolife Sweden ABRegulatory Specialists, Inc.3722 Ave. SausalitoIrvine, CA 92606TEL: 949.422.3853FAX: 949.552.2821EMAIL: greg@regulatoryspecialists.com |
| Date Prepared | November 17, 2017 |
| Trade NameCommon NameClassification NameRegulation NumberRegulatory ClassProduct Code | Follicle Aspiration Set, Reduced Single LumenOocyte Retrieval NeedleAssisted Reproduction Needles884.6100IIMQE (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.
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| 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 aspirationof 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 ButadieneStyrene (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:
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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<85> 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.
§ 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).