(270 days)
The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needles, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Endotoxin | < 20 EU/device (per ANSI/AAMI ST72-2011) | < 20 EU/device |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded blastocysts at 96 hours (1-Cell MEA) | ≥ 80% expanded blastocysts at 96 hours (1-Cell MEA) |
| Sterilization Validation | Per ISO 11135:2014 and ISO 10993-7:2008 | Passed validation |
| Package Integrity (Dye penetration) | Per ASTM F929-15 | Passed testing |
| Package Integrity (Seal strength) | Per ASTM F88/F88M-15 | Passed testing |
| Transport Testing | Per ASTM D4169-09 | Passed testing |
| Shelf-life (MEA) | ≥ 80% expanded blastocysts at 96 hours (1-Cell MEA) | Met at 3 years |
| Shelf-life (Endotoxin) | < 20 EU/device | Met at 3 years |
| Shelf-life (Tensile testing - needle to hub) | Internal requirements met | Met at 3 years |
| Shelf-life (Tensile testing - tubing to hub) | Internal requirements met | Met at 3 years |
| Shelf-life (Bending elasticity of needle) | Return to normal position after bending 8° from straight | Met at 3 years |
| Shelf-life (Folding strength of needle) | No fracture when folded at 5 mm curvature radius to 90° | Met at 3 years |
| Shelf-life (Device appearance) | No burrs, scratches, damage | Met at 3 years |
| Shelf-life (Dimensional assessments) | Internal requirements met | Met at 3 years |
| Aspiration pressure testing | Devices operated as intended (no deformation, blockages, damage) | Operated as intended |
| Biocompatibility (Cytotoxicity) | Acceptable results per ISO 10993-5:2009 | No signs of cytotoxicity |
| Biocompatibility (Intracutaneous reactivity) | Acceptable results per ISO 10993-10:2010 | No signs of irritation reactions |
| Biocompatibility (Sensitization) | Acceptable results per ISO 10993-10:2010 | No signs of sensitization reactions |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical performance tests. It does not specify a "test set" in the context of clinical data or human subjects. The testing involved various batches of the devices for each test. For example:
- Mouse Embryo Assay (MEA): "1-Cell mouse embryos were incubated in extracts of the subject device..." - The specific number of embryos or repetitions is not provided.
- Shelf-life studies: Performed on "real-time aged devices." The number of devices tested for each shelf-life parameter (MEA, endotoxin, tensile, bending, folding, appearance, dimensional) is not specified.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective, as these are non-clinical lab tests performed on the manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This report details non-clinical laboratory testing (e.g., chemical, mechanical, biological assays), not clinical studies requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by experts in the typical sense for clinical AI performance studies.
4. Adjudication Method for the Test Set:
Not applicable, as this is non-clinical laboratory testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes non-clinical performance testing of the device itself (e.g., material properties, sterility, embryotoxicity) and does not involve human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a medical device (needles), not an AI algorithm. The performance is assessed based on its physical and biological characteristics, not computational output.
7. Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on:
- Quantitative measurements: e.g., endotoxin levels (< 20 EU/device), percentage of expanded blastocysts (≥ 80%), specific dimensions.
- Qualitative observations: e.g., absence of deformation/blockages, no fracture, no burrs/scratches, no signs of cytotoxicity/sensitization/irritation.
- Adherence to established standards: e.g., ANSI/AAMI ST72-2011, ISO 11135:2014, ISO 10993-7:2008, ASTM F929-15, ASTM F88/F88M-15, ASTM D4169-09, ISO 10993-1-2009, ISO 10993-5:2009, ISO 10993-10:2010.
8. Sample Size for the Training Set:
Not applicable. This document pertains to the regulatory submission for a physical medical device, not an AI model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant here.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
Kitazato Corporation % Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K162881 Trade/Device Name: Kitazato OPU Needles Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MOE Dated: June 2, 2017 Received: June 2, 2017
Dear Audrey Swearingen:
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.
Joyce M. Whang -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}------------------------------------------------
Indications for Use
510(k) Number (if known) K162881
Device Name Kitazato OPU Needles
Indications for Use (Describe) The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain 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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{3}------------------------------------------------
510(k) Summary
Kitazato OPU Needles – K162881
1. Submission Sponsor
Kitazato Corporation 1-1-8 Shibadaimon, Minato-ku Tokyo 105-0012 JAPAN Contact: Ms. Mari Yazaki Title: Quality Assurance Manager Phone: (81) 3-3434-2731 Fax: (81) 3-3434-2732 Email: yazaki@kitazato.co.jp
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Audrey Swearingen, RAC Title: Director, Regulatory Affairs
3. Date Prepared
July 7, 2017
4. Device Identification
| Trade or Proprietary Name: | Kitazato OPU Needles |
|---|---|
| Common or Usual Name: | Oocyte aspiration needle |
| Regulation Number: | 884.6100 |
| Regulation Name: | Assisted Reproduction Needles |
| Product Code: | MQE |
| Product Code Name: | Needles, Assisted Reproduction |
| Class of Device: | Class II |
| Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Device(s)
KITAZATO Medical Co., Ltd., K112492, Kitazato OPU Needle with Connection Tube, Type2 and Kitazato OPU Reduced Needle, Type 3.
The predicate device has not been subject to a design-related recall.
Indication for Use Statement 6.
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube (model number Type2)
- Kitazato OPU Reduced Needle (model number Type3)
- Kitazato OPU Two-Stage Reduced Needle (model number Type4)
{4}------------------------------------------------
are intended to obtain oocytes from ovarian follicles.
7. Device Description
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
The Type2 OPU Needles consist of straight aspiration needles (no tapering) with the following characteristics:
| Model | ColorofHub | NeedleO.D.(mm) | NeedleGauge | NeedleLength(mm) | NeedleID(mm) | WallThickness(mm) | NeedleBevelAngle | ConnectionTubeLength(mm) | ConnectionTubeO.D.(mm) | ConnectionTubeID(mm) | StopperSize | TubesizeCompatiblewithStopper |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type2v1/-v10 | White | 1.65 | 16 | 350 | 1.19 | 0.23 | 14° | 800,1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2v2/v11 | Lightbrown | 1.49 | 17 | 350 | 1.06 | 0.22 | 14° | 800,1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2v3/v12 | Pink | 1.25 | 18 | 350 | 0.86 | 0.20 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2v4/v13 | Ivory | 1.06 | 19 | 350 | 0.74 | 0.16 | 14° | 800,1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
| Type2v5/v14 | Yellow | 0.90 | 20 | 350 | 0.64 | 0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2v6/v15 | Yellow | 0.90 | 20 | 300 | 0.64 | 0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2v7/v16 | Green | 0.80 | 21 | 300 | 0.54 | 0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2v8/v17 | Black | 0.70 | 22 | 300 | 0.43 | 0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2v9/v18 | Lightblue | 0.63 | 23 | 300 | 0.39 | 0.12 | 14° | 800,1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
The Type3 OPU Needles consist of aspiration needles with a tapered tip over the distal 40 or 100 mm of the tip. The table below shows the features of the Type3 OPU Needles:
| Model | ColorofHub | NeedleO.D.(mm)M: mainT:TaperedO.D. | NeedleGaugeM: mainT:TaperedGauge | NeedleLength(mm)TL:TaperedLength | NeedleID(mm)M: mainT:TaperedI.D. | WallThickness(mm) | NeedleBevelAngle | ConnectionTubeLength(mm) | ConnectionTubeO.D.(mm) | ConnectionTubeID(mm) | StopperSize | Tube sizeCompatiblewithStopper |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type3-v1 | Green | M 1.25T 0.80 | M 18T 21 | 300, 325350TL-40 | M-0.86T-0.54 | 0.195T-0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3-v2 | Black | M 1.25T 0.70 | M 18T 22 | 300, 325350T-40 | M-0.86T-0.45 | 0.195T-0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3-v3 | LightBlue | M 1.25T 0.63 | M 18T 23 | 300, 325T-40 | M-0.86T-0.43 | 0.195T-0.10 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3-v4 | Ivory | M 1.49T 1.06 | M 17T 19 | 300, 325350T-100 | M-1.20T-0.78 | 0.145T-0.14 | 14° | 800,1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type3-v5 | Yellow | M 1.49T 0.90 | M 17T 20 | 300, 325350T-100 | M-1.20T-0.62 | 0.145T-0.14 | 14° | 800,1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
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| Type3-v6 | Green | M 1.25T 0.80 | M 18T 21 | 300, 325T-100 | M-0.86T-0.54 | 0.195T-0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type3-v7 | Black | M 1.25T 0.70 | M 18T 22 | 300, 325T-100 | M-0.86T-0.45 | 0.195T-0.13 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3-v8 | LightBlue | M 1.25T 0.63 | M 18T 23 | 300, 325T-100 | M-0.86T-0.43 | 0.195T-0.10 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
The Type4 OPU Needles consist of aspiration needles that taper at two locations at the distal tip of the device, with the first taper beginning 70 mm from the tip and the second starting 25 mm from the tip. The table below shows the features of the Type4 OPU Needles.
| Model | ColorofHub | NeedleO.D.(mm)M: mainT1:1st StepTaperedT2 :2nd StepTapered | NeedleGaugeM: mainT1:1st StepTaperedT2:2nd StepTapered | NeedleLength(mm)M: mainT1:1st StepTaperedT2 :2nd StepTapered | NeedleID(mm)M: mainT2:2nd StepTapered | WallThickness(mm) | NeedleBevelAngle | ConnectionTubeLength(mm) | ConnectionTubeO.D.(mm) | ConnectionTubeID(mm) | StopperSize | Tube sizeCompatiblewithStopper |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type4-v1 | Green | M-1.25T1-1.06T2-0.80 | M-18/T1-19,T2-21 | M-300T1-70T2-25 | M-0.98T2-0.54 | 0.135 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4-v2 | Black | M-1.25T1-0.90T2-0.70 | M-18/T1-20T2-22 | M 300T1-70T2-25 | M-0.98T2-0.43 | 0.135 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4-v3 | LightBlue | M-1.25T1-0.80T2-0.63 | M-18/T1-21T2-23 | M-300T1-70T2-25 | M-0.98T2-0.39 | 0.135 | 14° | 800,1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
8. Substantial Equivalence Discussion
The following table compares the indications for use for the subject Kitazato OPU Needles and the predicate device:
| Subject Device | Predicate Device | Comments |
|---|---|---|
| K162881 | K112462 | |
| The Kitazato OPU Needlesconsisting of: | The Kitazato OPU Needlesconsisting of: | The intended use of the subjectand predicate devices is thesame. |
| Kitazato OPU Needle withConnection Tube (modelnumber Type2) Kitazato OPU Reduced Needle(model number Type3) Kitazato OPU Two-StageReduced Needle (modelnumber Type4) are intended to obtain oocytesfrom ovarian follicles. | Kitazato OPU Needle withConnection Tube (modelnumber Type2) Kitazato OPU Reduced Needle(model number Type3) are intended to obtain oocytesfrom ovarian follicles. |
The following tables compare the technological characteristics of the subject Kitazato OPU Needles to the predicate devices:
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Type2 OPU Needle Technological Characteristics Comparison
| Parameter | Subject DeviceType2 -OPU NeedleWith ConnectionTubeK162881 | Predicate DeviceType2 -OPU NeedleWith ConnectionTubeK112462 | Comments | ||||
|---|---|---|---|---|---|---|---|
| Lumen Type | Single | Single | Same | ||||
| TaperedNeedle | No | No | Same | ||||
| DeviceMaterials | Stainless steel (304) | Stainless steel (304) | Same | ||||
| ABS | ABS | ||||||
| PVC | PVC | ||||||
| Silicone | Silicone | ||||||
| PolypropyleneEpoxy resin | PolypropyleneEpoxy resin | ||||||
| NeedleGauge Range | 16-23 | 16-24 | Similar: The range of needle gauges for thesubject devices is within those of thepredicate devices. | ||||
| Needle ODRange | 0.63-1.65 mm | 0.55 -1.65 mm | Similar: The range of needle ODs for thesubject devices is within the range of thepredicates. | ||||
| NeedleLength Range | 300-350 mm | 200-350 mm | Different: The predicate devices are offered inadditional sizes that are not available for thesubject devices. These differences do notraise different questions of Safety andEffectiveness (S&E) as the range of needlelengths for the subject devices is within therange of the predicates. | ||||
| EchogenicMarker | Yes | Yes | Same | ||||
| ConnectionTube Length | 800-1000 mm | 200-1000 mm | Different: The predicate devices are offered inadditional sizes that are not available for thesubject devices. These differences do notraise different questions of S&E as the rangeof tubing lengths for the subject devices arewithin the range of the predicates. | ||||
| ConnectionTube OD | 2.0 | 2.0 | Same | ||||
| ConnectionTube Fitting | Silicone stopperwith attachedfemale connectorfor aspiration | Silicone stopperwith attachedfemale connectorfor aspiration | Same | ||||
| SterilizationMethod | Ethylene oxide | ||||||
| Single-Use/Repeat-Use | Single-Use | Single-Use | Same | ||||
| MEA | 1-Cell MEA: ≥80%expandedblastocysts at 96h | 1-Cell MEA: ≥80%expandedblastocysts at 96h | Same | ||||
| Endotoxin | <20 EU/device | <20 EU/device | Same |
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Type3 OPU Needle Technological Characteristics Comparison
| Parameter | Subject DeviceType3 -OPUReduced NeedleK162881 | Predicate DeviceType3 -OPUReduced NeedleK112462 | Comments |
|---|---|---|---|
| Lumen Type | Single | Single | Same |
| TaperedNeedle | Yes - single | Yes - single | Same |
| DeviceMaterials | Stainless steel (304)ABSPVCSiliconePolypropyleneEpoxy resin | Stainless steel (304)ABSPVCSiliconePolypropyleneEpoxy resin | Same |
| Needle GaugeRangeMain NeedleTapered End | 17-1819-23 | 1821-23 | Different: The range of needle gauges for thesubject devices is wider than those for thepredicate devices. These differences do notraise different S&E questions as compared tothe predicate devices. |
| Needle ODRangeMain NeedleTapered End | 1.25-1.49 mm0.63-1.06 | 0.55 -1.65 mmNot provided inpredicate | Different: The range of ODs for the predicatedevices is wider than those for the subjectdevices. These differences do not raisedifferent questions of S&E as all diameters ofthe subject devices are within the range ofODs of the predicate submission. |
| NeedleLength Range | 300-350 mm | 200-350 mm | Different: The predicate devices are offeredin additional sizes that are not available forthe subject devices. These differences donot raise different questions of S&E as therange of needle lengths for the subjectdevices are within the range of thepredicates. |
| Taper Length | 40-100 mm | 40-60 mm | Different: The subject devices are offeredwith a longer taper length than thepredicates. These differences do not raisedifferent questions of S&E as compared tothe predicates. |
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| the predicate devices. | |||
|---|---|---|---|
| EchogenicMarker | No | No | Same |
| ConnectionTube Length | 800-1000 mm | 200-1000 mm | Different: The predicate devices are offeredin additional sizes that are not available forthe subject devices. These differences donot raise different questions of S&E as therange of needle lengths for the subjectdevices are within the range of thepredicates. |
| ConnectionTube OD | 2.0 | 2.0 | Same |
| ConnectionTube Fitting | Silicone stopperwith attachedfemale connectorfor aspiration | Silicone stopperwith attachedfemale connectorfor aspiration | Same |
| SterilizationMethod | Ethylene oxide | Gamma radiation | Different – Both are accepted methods forsterilization of ART devices and do not raisedifferent questions of S&E as compared tothe predicate devices. |
| Single-Use/Repeat-Use | Single-Use | Single-Use | Same |
| MEA | 1-Cell MEA: ≥80%expandedblastocysts at 96h | 1-Cell MEA: ≥80%expandedblastocysts at 96h | Same |
| Endotoxin | <20 EU/device | <20 EU/device | Same |
Type4 Technological Characteristics Comparison
| Parameter | Subject DeviceType4 -OPU Two-Stage ReducedNeedleK162881 | Predicate DeviceType3 -OPUReduced NeedleK112462 | Comments |
|---|---|---|---|
| Lumen Type | Single | Single | Same |
| TaperedNeedle | Yes - double | Yes - single | Different: The subject devices taper at twopoints (25 and 70 mm from the tip), whilethe predicates only have a single taperoccurring between 40 and 60 mm from thetip. Dual vs. single tapering does not raisedifferent questions of S&E. |
| DeviceMaterials | Stainless steel (304) | Stainless steel (304) | Same |
| ABS | ABS | ||
| PVC | PVC | ||
| Silicone | Silicone | ||
| Polypropylene | Polypropylene | ||
| Epoxy resin | Epoxy resin | ||
| Needle Gauge Range | Same | ||
| Main NeedleTapered End | 1821-23 | 1821-23 | |
| Needle OD Range | Different: The range of ODs for the predicatedevices is wider than the ODs for the subjectdevices. These differences do not raisedifferent questions of S&E as all diameters ofthe devices in the subject submission arewithin the range of ODs of the predicates. | ||
| Main NeedleTapered End | 1.25 mm0.63-0.80 mm | 0.55 -1.65 mmNot in priorsubmission | |
| NeedleLength Range | 300 | 200-350 mm | Different: The predicate devices are offeredin additional sizes that are not available forthe subject devices. These differences donot raise different questions of S&E as therange of needle lengths for the subjectdevices are within the range of thepredicates. |
| EchogenicMarker | No | No | Same |
| ConnectionTube Length | 800-1000 mm | 200-1000 mm | Different: The predicate devices are offeredin additional sizes that are not available forthe subject devices. These differences donot raise different questions of S&E as therange of needle lengths for the subjectdevices are within the range of thepredicates. |
| ConnectionTube OD | 2.0 | 2.0 | Same |
| ConnectionTube Fitting | Silicone stopperwith attachedfemale connectorfor aspiration | Silicone stopperwith attachedfemale connectorfor aspiration | Same |
| Vacuum LineProvided | No | No | Same |
| SterilizationMethod | Ethylene oxide | Gamma radiation | Different – Both are accepted methods forsterilization of ART devices and do not raisedifferent questions of S&E as compared tothe predicate devices. |
| Single-Use/Repeat-Use | Single-Use | Single-Use | Same |
| MEA | 1-Cell MEA: ≥80%expandedblastocysts at 96h | 1-Cell MEA: ≥80%expandedblastocysts at 96h | Same |
| Endotoxin | <20 EU/device | <20 EU/device | Same |
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As noted in the tables above, there are many similarities between the subject and predicate devices (e.g., materials, designs, etc.); however, differences do exist. The differences in technology noted in the tables above, do not raise different questions of safety or effectiveness as compared to the predicate device.
9. Non-Clinical Performance Data
As part of demonstrating substantial equivalence to the following non-clinical performance tests were conducted. The Kitazato OPU Needles passed all of the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:
- Endotoxin testing per ANSI/AAMI ST72-2011: <20 EU/device .
- Mouse Embryo Assay (MEA): 1-Cell mouse embryos were incubated in extracts of the subject device at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group. The acceptance criterion was 1-Cell MEA: ≥80% expanded to blastocyst at 96 hours.
- Sterilization validation per ISO 11135:2014 and ISO 10993-7:2008 ●
- Package integrity testing following real-time aging:
- o Dye penetration testing per ASTM F929-15
- o Seal strength testing per ASTM F88/F88M-15
- o Dye penetration testing per ASTM F929-15
- Transport testing per ASTM D4169-09
- Shelf-life studies (real-time aged devices) were conducted to ensure that the following product ● specifications were met to support a three-year shelf-life:
- O MEA
- O Endotoxin
- Tensile testing (needle to hub and tubing to hub) O
- O Bending elasticity of needle – Return to normal position after bending 8° from straight
- Folding strength of needle No fracture of needle when folded at a 5 mm curvature radius O to 90°
- o Device appearance (burrs, scratches, damage)
- Dimensional assessments O
- . Aspiration pressure testing - Testing involved aspirating water through needles at the recommended aspiration pressures included in device labeling to ensure that devices operated as intended (i.e., no signs of deformation, blockages or damage)
- Biocompatibility testing was conducted according to ISO 10993-1- 2009. Testing included cytotoxicity (ISO 10993-5:2009), intracutaneous reactivity (ISO 10993-10:2010), and sensitization (ISO 10993-10:2010). The test articles assessed provided acceptable results as no signs of cytotoxicity, sensitization or irritation reactions were noted in testing.
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10. Conclusion
The results of the testing described above demonstrate that the Kitazato OPU Needles are 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).