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.

AI/ML Overview

The provided text describes the Follicle Aspiration Set, outlining its design, intended use, and comparison to a predicate device. It also includes information about performance testing to establish substantial equivalence.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mouse Embryo Assay (MEA): ≥ 80% expanded blastocysts within 96 hours (1-Cell MEA)	Met: > 80% expanded blastocysts within 96 hours (1-Cell MEA)
Endotoxins: < 1.2 EU/device	Met: ≤ 1.2 EU/device
Vacuum Testing: Operate as intended under -500 mmHg vacuum without signs of damage	Met: Devices were shown to operate as intended without signs of damage.
Flow Testing: Flow rates within anticipated ranges under intended use conditions	Met: Testing was conducted to assess that flow rates were within anticipated ranges under intended use conditions.
Sterilization Validation per ISO 11137-2:2013	Met: Confirmed by Sterilization Validation per ISO 11137-2:2013.
Biocompatibility: Non-cytotoxic	Met: Device extracts assessed were non-cytotoxic.
Biocompatibility: Non-sensitizing	Met: Device extracts assessed were non-sensitizing.
Biocompatibility: Non-irritating	Met: Device extracts assessed were non-irritating.
Mechanical Testing (Breakage, Bend, Stiffness per ISO 9626:2016)	Met: Testing conducted per ISO 9626:2016. (Specific results not detailed but implied to be sufficient for a substantial equivalence determination).
Tensile Strength Testing	Met: Testing conducted. (Specific results not detailed but implied to be sufficient for a substantial equivalence determination).
Shelf-life (3 years): 1-cell MEA ≥80% expanded blastocysts within 96 hours	Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion).
Shelf-life (3 years): Standard Test Method for Seal Strength of Flexible Barrier Materials per ASTM F88 / F88M - 09	Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion).
Shelf-life (3 years): Dye Penetration per ASTM F1929 12	Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion).
Shelf-life (3 years): Visual Inspection per ASTM F1886 / F1886M 09	Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion).
Shelf-life (3 years): Tensile Strength Testing	Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify human test subjects or clinical data for the "test set" in the context of typical AI/software studies. The testing described is primarily non-clinical, involving laboratory and mechanical evaluations of the physical device. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a physical medical instrument (Follicle Aspiration Set), and the testing performed relates to its physical, chemical, and biological properties (e.g., sterilization, endotoxins, MEA, mechanical strength, biocompatibility). It does not involve the interpretation of data by human experts in the way an AI diagnostic tool would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. The testing methods described are objective laboratory or standardized mechanical tests, not subjective assessments requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic or assistive technologies, where human performance is measured with and without AI. The Follicle Aspiration Set is a physical medical device, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation (as typically understood for an algorithm) was not conducted because the device is a physical instrument, not an algorithm. The "standalone" performance here refers to the device's intrinsic mechanical, chemical, and biological properties, which were evaluated through the performance testing listed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance testing is based on established scientific and engineering standards and methods:

Mouse Embryo Assay (MEA): The development of mouse embryos to the expanded blastocyst stage is a biological endpoint widely accepted in ART for assessing the embryotoxicity of materials.
Endotoxin testing (USP<85>, LAL): Standardized biochemical tests for the presence and quantity of endotoxins.
Sterilization Validation (ISO 11137-2:2013): International standard for radiation sterilization.
Mechanical Testing (ISO 9626:2016, Tensile Strength): International and industry standards for needle properties and material strength.
Biocompatibility Testing (ISO 10993-5, 10, 1): International standards for evaluating the biological effects of medical devices.
Packaging Testing (ASTM F88/F88M, F1929, F1886/F1886M): American Society for Testing and Materials standards for package integrity.

These are objective, quantitative, and qualitative measures against defined standards or biological responses, rather than subjective ground truths established by human experts or outcomes data in a clinical trial.

8. The sample size for the training set

This information is not applicable. The device is a manufactured medical instrument, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this physical device.

Summary

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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

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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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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.

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Device Description:

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.

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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:

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

	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

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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 flushingand/or aspiration ofoocytes from ovarianfollicles	The swemed follicle aspirationset, double lumen, swemedfollicle aspiration set, singlelumen, and swemed follicleaspiration luer needle andintended to obtain gametesfrom the body are speciallyindicated for flushing and/oraspiration of oocytes fromovarian follicles.
Materials
Aspiration needle	Stainless steel	Stainless steel
Needle grip	Stainless steel	Stainless steel
Aspiration tubing	Polyolefin basedTPE (TPE-0)	Teflon
Cork	Silicone	Silicone
Cork adapter	Bent blunt cannulamounted on the corkAdapter/ bluntcannula is notneeded for a syringewith luer slip.Syringe with luerlock - new adapter isneeded to be able toconnect to the cork	Straight Blunt Stainless steelcannula (can be used to connecta vacuum pump)An adapter (a blunt cannula) isalways needed to be able toconnect a syringe to the cork.
Cannula Luer	Methyl MethacrylateAcrylonitrileButadiene Styrene	Polypropylene luer lockconnection
Cannula for flushing	Stainless steel	Stainless steel
Protective sheath	Polypropylene	Not provided

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K161970

Bonding	Epoxy resin	Epoxy resin
Packaging	Tyvek+Polyethlene/Polypropylene (cleartransparent)	Paper +Polyethlene/Polypropylene(green transparent)
Sterility	Radiation	Steam
Mouse Embryo Assay (MEA)	1-Cell MEA: ≥ 80 %expanded blastocystswithin 96 hours.	2-Cell MEA
Endotoxins	< 1.2 EU/ device	< 1.2 EU/ device
Design Features
Follicle Aspiration set, single lumen
Needle length (straight)	250,300, 330, 350(mm)	200, 250, 300, 350 (mm)
Needle Outer Diameter	1.2, 1.4, 1.6 (mm)	1.2, 1.4 , 1.5 , 1.6 (mm)
Needle Inner Diameter	1.0, 1.1, 1.2 (mm)	0.8-1.3 (mm)
Aspiration tube length	400, 600, 750, 900(mm)	400, 600, 900
Tubing Outer diameter	2.22 & 2.32 (mm)	1.67, 1.95 (mm)
Tubing Inner diameter	1.33, 1.43, 1.53(mm)	1.07, 1.35 (mm)
Vacuum Tubing	600 mm	NA
Follicle Aspiration set, double lumen
Needle length (Inner and outer needle)-Outer-Inner	250, 300 & 350(mm)300, 350 & 400(mm)	250-350 (mm)
Outer Needle Diameter-Outer-Inner	- 1.5 & 1.65 (mm)-1.3 & 1.45 (mm)	1.2, 1.6 (mm)0.8, 1.0
Inner Needle Diameter-Outer-Inner	- 1.1 & 1.2 (mm)- 0.9 & 1.0 (mm)	NA
Aspiration tube length	400, 600, 900, 1000(mm)	400, 600, 900
Aspiration Tubing Outer diameter	2.32 (mm)	1.67, 1.95 (mm)
Aspiration Tubing Inner diameter	1.43 (mm)	1.07 , 1.35 (mm)
End of Flushing tube	Blunt cannula OD/ID1.5/1.3 mm	Hub with hole 1.2 mm
Flush Tube Length	400, 600, 900, 1000 (mm)	300, 400, 600, 900
Flush Tube Outer Diameter	2.22 (mm)	Not provided
Flush Tube Inner Diameter	1.33 (mm)	Not provided
Vacuum Tube	900 (mm)	Not provided
Vacuum Outer Diameter	2.32 (mm)	Not provided
Vacuum Inner Diameter	1.43 (mm)	Not provided
Follicle Aspiration Set, Single Lumen, Luer with Tubing
Needle Length	300 (mm)	200, 250, 300, 350 (mm)
Needle Outer Diameter	1.5 (mm)	1.2, 1.4, 1.5, 1.6 (mm)
Needle Inner Diameter	1.2 (mm)	0.8-1.3 (mm)
Tubing Length	600 (mm)	200, 250, 300, 350 (mm)
Tubing Outer Diameter	2.32 (mm)	1.2, 1.4, 1.5, 1.6 (mm)
Tubing Inner Diameter	1.43 (mm)	0.8-1.3 (mm)
Leur Connector on Aspiration Tubing	Yes	No
Follicle Aspiration Set, Single Lumen, Luer
Needle Length	250,300,350 (mm)	250, 300, 350 (mm)
Needle Outer Diameter	1.2,1.4,1.6 (mm)	1.2, 1.4, 1.6 (mm)
Needle Inner Diameter	0.8,1.2,1.3 (mm)	0.8, 1.0 1.2, 1.3 (mm)

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K161970 Page 6 of 9

The indications for use statements for the subject and predicate devices are similar in that they are both for use in flushing and retrieval of oocytes from ovarian follicles. Therefore, these devices have the same intended uses.

The subject and predicate devices are similar in some technological features, including design (e.g., needle material, needle length, lumen type, tip shape, cork material, etc.). However, there are a number of differences between the subject and predicate device that are described below:

. Device materials - Some of the device materials (e.g., tubing, luer, etc.) are not the same. Materials differences are common in Assisted Reproduction Technology (ART) devices and do not raise different questions of safety and effectiveness, and can be addressed through testing (e.g., MEA, biocompatibility, performance).
Tubing Dimensions - Dimensions of all the design types are slightly different from the predicate device (e.g., length and diameter). Differences in dimensions noted in the table above do not raise different questions of safety and effectiveness (e.g., ability to withstand vacuum pressures during use, etc.) and differences can be assessed through performance testing.

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. Needle Dimensions - There is slight difference in needle length and diameter for all device types. Variations in needle length occur in ART oocyte aspiration needles and do not raise different questions of safety or effectiveness (e.g., sufficient length to aspirate oocytes, diameter compatible with dimensions of oocytes). Performance data can be used to support these types of differences
. Device design - 1) The subject device has a bent (45 degrees) cannula mounted on cork for easier access for connection of a vacuum pump, whereas the predicate device has a straight cannula. 2) For the double lumen aspiration kit, the subject device has a blunt cannula at the end of the flushing tube, while the predicate device has a luer fitting. 3) The subject device has an additional device type, Single Lumen Luer with Tubing, while the corresponding predicate device is described as a Single Lumen (i.e., no leur at end of tubing) . The modification of adding leur fitting to the end of the tubing, modifying the cork and cannula design/geometry, and the addition of a blunt cannula do not raise different questions of safety and effectiveness and differences can be assessed through performance testing. . The Single Lumen Luer with tubing has not been previously cleared in the predicate; however, the technology is similar to the devices within this submission and previously cleared devices with the same intended use.
. Packaging material- the subject device uses Tyvek and clear polyethylene/polypropylene, whereas the predicate device uses paper and green transparent material. The material differences in packaging are common and do not raise different questions of safety and effectiveness, and can be addressed through testing (e.g., package integrity).
. The subject device MEA assay has an acceptance criterion of > 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<85>, 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.

Regulation Number and Section

§ 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).