Kitazato OPU Needles

K162881 · Kitazato Corporation · MQE · Jul 11, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162881
• Device Name: Kitazato OPU Needles
• Applicant: Kitazato Corporation
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Jul 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

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.

Device Story

Kitazato OPU Needles are single-use, sterile, ultrasound-guided transvaginal needles used to collect oocytes from ovarian follicles. The device consists of a 304 stainless steel needle, ABS hub, PVC connection tube, and silicone stopper. It connects to a vacuum pump for aspiration. The device is operated by a physician in a clinical setting. The needle tip enters the follicle under ultrasound guidance; vacuum pressure draws the oocyte through the needle and tube into a collection vessel. The device facilitates oocyte retrieval for assisted reproduction, directly impacting the success of subsequent fertilization procedures. Variations include straight (Type2), single-tapered (Type3), and double-tapered (Type4) designs to accommodate different clinical needs.

Clinical Evidence

Bench testing only. Testing included: Endotoxin levels (<20 EU/device); Mouse Embryo Assay (MEA) (≥80% blastocyst development at 96h); sterilization validation (ISO 11135, ISO 10993-7); package integrity (ASTM F929-15, ASTM F88/F88M-15); transport testing (ASTM D4169-09); shelf-life studies (3-year); aspiration pressure testing; and biocompatibility (ISO 10993-1, including cytotoxicity, sensitization, and intracutaneous reactivity). All tests met acceptance criteria.

Technological Characteristics

Materials: 304 stainless steel, ABS, PVC, silicone, polypropylene, epoxy resin. Design: Single-lumen aspiration needles; straight, single-tapered, or double-tapered tips. Dimensions: 16-23 gauge; 300-350 mm length. Sterilization: Ethylene oxide. Connectivity: None (mechanical).

Indications for Use

Indicated for obtaining oocytes from ovarian follicles in patients undergoing assisted reproduction procedures.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Predicate Devices

• Kitazato OPU Needle with Connection Tube, Type2 and Kitazato OPU Reduced Needle, Type 3 (K112492)

Submission Summary (Full Text)

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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.

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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 (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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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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# 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: [phone] Fax: [phone] Email: [e-mail]

## 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] 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)

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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 | Color<br>of<br>Hub | Needle<br>O.D.<br>(mm) | Needle<br>Gauge | Needle<br>Length<br>(mm) | Needle<br>ID<br>(mm) | Wall<br>Thickness<br>(mm) | Needle<br>Bevel<br>Angle | Connection<br>Tube<br>Length<br>(mm) | Connection<br>Tube<br>O.D.<br>(mm) | Connection<br>Tube<br>ID<br>(mm) | Stopper<br>Size | Tube<br>size<br>Compatible<br>with<br>Stopper |
|------------------|--------------------|------------------------|-----------------|--------------------------|----------------------|---------------------------|--------------------------|--------------------------------------|------------------------------------|----------------------------------|-----------------|-----------------------------------------------|
| Type2<br>v1/-v10 | White | 1.65 | 16 | 350 | 1.19 | 0.23 | 14° | 800,<br>1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2<br>v2/v11 | Light<br>brown | 1.49 | 17 | 350 | 1.06 | 0.22 | 14° | 800,<br>1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2<br>v3/v12 | Pink | 1.25 | 18 | 350 | 0.86 | 0.20 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2<br>v4/v13 | Ivory | 1.06 | 19 | 350 | 0.74 | 0.16 | 14° | 800,<br>1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
| Type2<br>v5/v14 | Yellow | 0.90 | 20 | 350 | 0.64 | 0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2<br>v6/v15 | Yellow | 0.90 | 20 | 300 | 0.64 | 0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2<br>v7/v16 | Green | 0.80 | 21 | 300 | 0.54 | 0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2<br>v8/v17 | Black | 0.70 | 22 | 300 | 0.43 | 0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2<br>v9/v18 | Light<br>blue | 0.63 | 23 | 300 | 0.39 | 0.12 | 14° | 800,<br>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 | Color<br>of<br>Hub | Needle<br>O.D.<br>(mm)<br>M: main<br>T:<br>Tapered<br>O.D. | Needle<br>Gauge<br>M: main<br>T:<br>Tapered<br>Gauge | Needle<br>Length<br>(mm)<br>TL:<br>Tapered<br>Length | Needle<br>ID<br>(mm)<br>M: main<br>T:<br>Tapered<br>I.D. | Wall<br>Thick<br>ness<br>(mm) | Needle<br>Bevel<br>Angle | Connec<br>tion<br>Tube<br>Length<br>(mm) | Connec<br>tion<br>Tube<br>O.D.<br>(mm) | Connec<br>tion<br>Tube<br>ID<br>(mm) | Stopper<br>Size | Tube size<br>Compatible<br>with<br>Stopper |
|--------------|--------------------|------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------|-------------------------------|--------------------------|------------------------------------------|----------------------------------------|--------------------------------------|-----------------|--------------------------------------------|
| Type3<br>-v1 | Green | M 1.25<br>T 0.80 | M 18<br>T 21 | 300, 325<br>350<br>TL-40 | M-0.86<br>T-0.54 | 0.195<br>T-0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3<br>-v2 | Black | M 1.25<br>T 0.70 | M 18<br>T 22 | 300, 325<br>350<br>T-40 | M-0.86<br>T-0.45 | 0.195<br>T-0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3<br>-v3 | Light<br>Blue | M 1.25<br>T 0.63 | M 18<br>T 23 | 300, 325<br>T-40 | M-0.86<br>T-0.43 | 0.195<br>T-0.10 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3<br>-v4 | Ivory | M 1.49<br>T 1.06 | M 17<br>T 19 | 300, 325<br>350<br>T-100 | M-1.20<br>T-0.78 | 0.145<br>T-0.14 | 14° | 800,<br>1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type3<br>-v5 | Yellow | M 1.49<br>T 0.90 | M 17<br>T 20 | 300, 325<br>350<br>T-100 | M-1.20<br>T-0.62 | 0.145<br>T-0.14 | 14° | 800,<br>1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |

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| Type3<br>-v6 | Green | M 1.25<br>T 0.80 | M 18<br>T 21 | 300, 325<br>T-100 | M-0.86<br>T-0.54 | 0.195<br>T-0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
|--------------|---------------|------------------|--------------|-------------------|------------------|-----------------|-----|--------------|-----|-----|-----|-----------|
| Type3<br>-v7 | Black | M 1.25<br>T 0.70 | M 18<br>T 22 | 300, 325<br>T-100 | M-0.86<br>T-0.45 | 0.195<br>T-0.13 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3<br>-v8 | Light<br>Blue | M 1.25<br>T 0.63 | M 18<br>T 23 | 300, 325<br>T-100 | M-0.86<br>T-0.43 | 0.195<br>T-0.10 | 14° | 800,<br>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 | Color<br>of<br>Hub | Needle<br>O.D.<br>(mm)<br>M: main<br>T1:<br>1st Step<br>Tapered<br>T2 :<br>2nd Step<br>Tapered | Needle<br>Gauge<br>M: main<br>T1:<br>1st Step<br>Tapered<br>T2:<br>2nd Step<br>Tapered | Needle<br>Length<br>(mm)<br>M: main<br>T1:<br>1st Step<br>Tapered<br>T2 :<br>2nd Step<br>Tapered | Needle<br>ID<br>(mm)<br>M: main<br>T2:<br>2nd Step<br>Tapered | Wall<br>Thickness<br>(mm) | Needle<br>Bevel<br>Angle | Connec<br>tion<br>Tube<br>Length<br>(mm) | Connec<br>tion<br>Tube<br>O.D.<br>(mm) | Connec<br>tion<br>Tube<br>ID<br>(mm) | Stopper<br>Size | Tube size<br>Compatible<br>with<br>Stopper |
|--------------|--------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------|--------------------------|------------------------------------------|----------------------------------------|--------------------------------------|-----------------|--------------------------------------------|
| Type4<br>-v1 | Green | M-1.25<br>T1-1.06<br>T2-0.80 | M-18/<br>T1-19,<br>T2-21 | M-300<br>T1-70<br>T2-25 | M-0.98<br>T2-0.54 | 0.135 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4<br>-v2 | Black | M-1.25<br>T1-0.90<br>T2-0.70 | M-18/<br>T1-20<br>T2-22 | M 300<br>T1-70<br>T2-25 | M-0.98<br>T2-0.43 | 0.135 | 14° | 800,<br>1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4<br>-v3 | Light<br>Blue | M-1.25<br>T1-0.80<br>T2-0.63 | M-18/<br>T1-21<br>T2-23 | M-300<br>T1-70<br>T2-25 | M-0.98<br>T2-0.39 | 0.135 | 14° | 800,<br>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 Needles<br>consisting of: | The Kitazato OPU Needles<br>consisting of: | The intended use of the subject<br>and predicate devices is the<br>same. |
| Kitazato OPU Needle with<br>Connection Tube (model<br>number Type2) Kitazato OPU Reduced Needle<br>(model number Type3) Kitazato OPU Two-Stage<br>Reduced Needle (model<br>number Type4) are intended to obtain oocytes<br>from ovarian follicles. | Kitazato OPU Needle with<br>Connection Tube (model<br>number Type2) Kitazato OPU Reduced Needle<br>(model number Type3) are intended to obtain oocytes<br>from 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 Device<br>Type2 -OPU Needle<br>With Connection<br>Tube<br>K162881 | Predicate Device<br>Type2 -OPU Needle<br>With Connection<br>Tube<br>K112462 | Comments | | | | |
|-------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Type | Single | Single | Same | | | | |
| Tapered<br>Needle | No | No | Same | | | | |
| Device<br>Materials | Stainless steel (304) | Stainless steel (304) | Same | | | | |
| | ABS | ABS | | | | | |
| | PVC | PVC | | | | | |
| | Silicone | Silicone | | | | | |
| | Polypropylene<br>Epoxy resin | Polypropylene<br>Epoxy resin | | | | | |
| Needle<br>Gauge Range | 16-23 | 16-24 | Similar: The range of needle gauges for the<br>subject devices is within those of the<br>predicate devices. | | | | |
| | Needle OD<br>Range | 0.63-1.65 mm | | 0.55 -1.65 mm | Similar: The range of needle ODs for the<br>subject devices is within the range of the<br>predicates. | | |
| | | Needle<br>Length Range | | 300-350 mm | | 200-350 mm | Different: The predicate devices are offered in<br>additional sizes that are not available for the<br>subject devices. These differences do not<br>raise different questions of Safety and<br>Effectiveness (S&E) as the range of needle<br>lengths for the subject devices is within the<br>range of the predicates. |
| Echogenic<br>Marker | | | Yes | Yes | | Same | |
| Connection<br>Tube Length | 800-1000 mm | | 200-1000 mm | Different: The predicate devices are offered in<br>additional sizes that are not available for the<br>subject devices. These differences do not<br>raise different questions of S&E as the range<br>of tubing lengths for the subject devices are<br>within the range of the predicates. | | | |
| | Connection<br>Tube OD | | 2.0 | | 2.0 | Same | |
| | Connection<br>Tube Fitting | | Silicone stopper<br>with attached<br>female connector<br>for aspiration | | Silicone stopper<br>with attached<br>female connector<br>for aspiration | Same | |
| | | | Sterilization<br>Method | | Ethylene oxide | | |
| | | | | | | | |
| Single-<br>Use/Repeat-<br>Use | | Single-Use | | Single-Use | Same | | |
| MEA | 1-Cell MEA: ≥80%<br>expanded<br>blastocysts at 96h | 1-Cell MEA: ≥80%<br>expanded<br>blastocysts at 96h | Same | | | | |
| Endotoxin | <20 EU/device | <20 EU/device | Same | | | | |

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# Type3 OPU Needle Technological Characteristics Comparison

| Parameter | Subject Device<br>Type3 -OPU<br>Reduced Needle<br>K162881 | Predicate Device<br>Type3 -OPU<br>Reduced Needle<br>K112462 | Comments |
|-----------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Type | Single | Single | Same |
| Tapered<br>Needle | Yes - single | Yes - single | Same |
| Device<br>Materials | Stainless steel (304)<br>ABS<br>PVC<br>Silicone<br>Polypropylene<br>Epoxy resin | Stainless steel (304)<br>ABS<br>PVC<br>Silicone<br>Polypropylene<br>Epoxy resin | Same |
| Needle Gauge<br>Range<br>Main Needle<br>Tapered End | 17-18<br>19-23 | 18<br>21-23 | Different: The range of needle gauges for the<br>subject devices is wider than those for the<br>predicate devices. These differences do not<br>raise different S&E questions as compared to<br>the predicate devices. |
| Needle OD<br>Range<br>Main Needle<br>Tapered End | 1.25-1.49 mm<br>0.63-1.06 | 0.55 -1.65 mm<br>Not provided in<br>predicate | Different: The range of ODs for the predicate<br>devices is wider than those for the subject<br>devices. These differences do not raise<br>different questions of S&E as all diameters of<br>the subject devices are within the range of<br>ODs of the predicate submission. |
| Needle<br>Length Range | 300-350 mm | 200-350 mm | Different: The predicate devices are offered<br>in additional sizes that are not available for<br>the subject devices. These differences do<br>not raise different questions of S&E as the<br>range of needle lengths for the subject<br>devices are within the range of the<br>predicates. |
| Taper Length | 40-100 mm | 40-60 mm | Different: The subject devices are offered<br>with a longer taper length than the<br>predicates. These differences do not raise<br>different questions of S&E as compared to<br>the predicates. |

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| | | | the predicate devices. |
|-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Echogenic<br>Marker | No | No | Same |
| Connection<br>Tube Length | 800-1000 mm | 200-1000 mm | Different: The predicate devices are offered<br>in additional sizes that are not available for<br>the subject devices. These differences do<br>not raise different questions of S&E as the<br>range of needle lengths for the subject<br>devices are within the range of the<br>predicates. |
| Connection<br>Tube OD | 2.0 | 2.0 | Same |
| Connection<br>Tube Fitting | Silicone stopper<br>with attached<br>female connector<br>for aspiration | Silicone stopper<br>with attached<br>female connector<br>for aspiration | Same |
| Sterilization<br>Method | Ethylene oxide | Gamma radiation | Different – Both are accepted methods for<br>sterilization of ART devices and do not raise<br>different questions of S&E as compared to<br>the predicate devices. |
| Single-<br>Use/Repeat-<br>Use | Single-Use | Single-Use | Same |
| MEA | 1-Cell MEA: ≥80%<br>expanded<br>blastocysts at 96h | 1-Cell MEA: ≥80%<br>expanded<br>blastocysts at 96h | Same |
| Endotoxin | <20 EU/device | <20 EU/device | Same |

# Type4 Technological Characteristics Comparison

| Parameter | Subject Device<br>Type4 -OPU Two-<br>Stage Reduced<br>Needle<br>K162881 | Predicate Device<br>Type3 -OPU<br>Reduced Needle<br>K112462 | Comments |
|-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Type | Single | Single | Same |
| Tapered<br>Needle | Yes - double | Yes - single | Different: The subject devices taper at two<br>points (25 and 70 mm from the tip), while<br>the predicates only have a single taper<br>occurring between 40 and 60 mm from the<br>tip. Dual vs. single tapering does not raise<br>different questions of S&E. |
| Device<br>Materials | Stainless steel (304) | Stainless steel (304) | Same |
| | ABS | ABS | |
| | PVC | PVC | |
| | Silicone | Silicone | |
| | Polypropylene | Polypropylene | |
| | Epoxy resin | Epoxy resin | |
| Needle Gauge Range | | | Same |
| Main Needle<br>Tapered End | 18<br>21-23 | 18<br>21-23 | |
| Needle OD Range | | | Different: The range of ODs for the predicate<br>devices is wider than the ODs for the subject<br>devices. These differences do not raise<br>different questions of S&E as all diameters of<br>the devices in the subject submission are<br>within the range of ODs of the predicates. |
| Main Needle<br>Tapered End | 1.25 mm<br>0.63-0.80 mm | 0.55 -1.65 mm<br>Not in prior<br>submission | |
| Needle<br>Length Range | 300 | 200-350 mm | Different: The predicate devices are offered<br>in additional sizes that are not available for<br>the subject devices. These differences do<br>not raise different questions of S&E as the<br>range of needle lengths for the subject<br>devices are within the range of the<br>predicates. |
| Echogenic<br>Marker | No | No | Same |
| Connection<br>Tube Length | 800-1000 mm | 200-1000 mm | Different: The predicate devices are offered<br>in additional sizes that are not available for<br>the subject devices. These differences do<br>not raise different questions of S&E as the<br>range of needle lengths for the subject<br>devices are within the range of the<br>predicates. |
| Connection<br>Tube OD | 2.0 | 2.0 | Same |
| Connection<br>Tube Fitting | Silicone stopper<br>with attached<br>female connector<br>for aspiration | Silicone stopper<br>with attached<br>female connector<br>for aspiration | Same |
| Vacuum Line<br>Provided | No | No | Same |
| Sterilization<br>Method | Ethylene oxide | Gamma radiation | Different – Both are accepted methods for<br>sterilization of ART devices and do not raise<br>different questions of S&E as compared to<br>the predicate devices. |
| Single-<br>Use/Repeat-<br>Use | Single-Use | Single-Use | Same |
| MEA | 1-Cell MEA: ≥80%<br>expanded<br>blastocysts at 96h | 1-Cell MEA: ≥80%<br>expanded<br>blastocysts 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
- 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.