KITAZATO OPU NEEDLE

K112462 · Kitazato Medical Co., Ltd. · MQE · Nov 26, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112462
• Device Name: KITAZATO OPU NEEDLE
• Applicant: Kitazato Medical Co., Ltd.
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Nov 26, 2012
• 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 Type 2 - Kitazato OPU Reduced Needle, model number Type 3 are intended to obtain oocytes from ovarian follicles.

Device Story

Kitazato OPU Needles are sterile, single-use devices designed for transvaginal puncture of ovarian follicles to aspirate oocytes. The device consists of a stainless steel aspiration needle, a connection tube, and a silicone stopper connector. Available in two configurations: Type 2 (standard aspiration needle) and Type 3 (reduced needle with a narrow tip). The clinician performs the procedure under ultrasound guidance to locate follicles, punctures the vaginal wall, and aspirates the follicular fluid containing oocytes. The output is the collected oocyte sample, which is then processed in a laboratory setting for assisted reproduction. The device facilitates oocyte retrieval, a critical step in IVF and other fertility treatments.

Clinical Evidence

Bench testing only. Testing included mechanical tensile strength (withstanding 22N for O.D. <0.55mm), bending elasticity (returning to position after 8° bend), folding strength (no fracture at 90°), dimensional verification, endotoxin levels (≤20 EU/device), and sterility. Mouse embryo assay demonstrated ≥80% expansion to blastocyst stage within 96 hours, confirming biocompatibility for reproductive use.

Technological Characteristics

Needle assembly consisting of stainless steel needle, connection tube, and silicone stopper. Available in gauges 16G to 24G (Type 2) and 18G with 21G-23G narrow tips (Type 3). Sterilized device. Biocompatibility verified per international standards.

Indications for Use

Indicated for patients undergoing oocyte retrieval from ovarian follicles for 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

• Vitrolife Sweden AB -- Follicle Aspiration Set, Reduced Single Lumen (K082727)
• Swemed Lab International AB - Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle (K991273)

Submission Summary (Full Text)

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K112462
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## 510(k) Summary

For

NOV 2 6 2012

# Kitazato OPU Needle

### 1. Submission Sponsor

KITAZATO Medical Co., Ltd. 2-15-12 Hongo, Bunkyou-ku Tokyo 113-0033 JAPAN Phone: +(81) 3-5800-6055 Fax: +(81) 3-5800-6056 Contact: Mari Yazaki, Quality Assurance Manager

#### 2. Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] Contact: Richard Vincins, Vice President, QA Email: [e-mail]

#### 3. Date Prepared

21 November 2012

·

#### 4. Device Name

| Trade/Proprietary Name: | Kitazato OPU Needle with Connection Tube, model number<br>Type 2<br>Kitazato OPU Reduced Needle, model number Type 3 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | OPU Needle |
| Classification Name: | Assisted Reproduction Needles |
| Classification Regulation: | 884.6100 |
| Classification Panel: | Obstetrics/Gynecology |
| Product Code: | MQE |
| Device Class: | II |

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K112462
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#### 5. Predicate Devices

Vitrolife Sweden AB -- Follicle Aspiration Set, Reduced Single Lumen (K082727) Swemed Lab International AB - Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle (K991273)

#### Device Description 6.

The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.

The OPU Needle with Connection Tube, model number Type 2, includes the following models:

| Model | Color of<br>Hub | Needle<br>O.D. (mm) | Needle<br>Gauge | Needle Length (mm) | Connection Tube Length (mm) |
|-----------|-----------------|---------------------|-----------------|-----------------------------------|-------------------------------|
| Type2 -v1 | White | 1.65 | 16 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v2 | Light<br>brown | 1.49 | 17 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v3 | Pink | 1.25 | 18 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v4 | Ivory | 1.06 | 19 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v5 | Yellow | 0.90 | 20 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v6 | Green | 0.80 | 21 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v7 | Black | 0.70 | 22 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v8 | Light<br>blue | 0.63 | 23 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v9 | Purple | 0.55 | 24 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |

The OPU Reduced Needle, mode number Type 3, includes the following models:

| Model | Needle<br>Gauge | Needle<br>Q.D.<br>(mm) | Narrow<br>Tip<br>Gauge | Narrow<br>Tip O.D.<br>(mm) | Needle Length<br>(mm) | Color of<br>Hub | Length of<br>Reduced<br>Needle<br>(mm) | Connection<br>Tube<br>Length<br>(mm) |
|-----------|-----------------|------------------------|------------------------|----------------------------|--------------------------------------|-----------------|----------------------------------------|--------------------------------------|
| Type3 -v1 | 18 | 1.25 | 21 | 0.80 | 200, 225, 250,<br>275, 300, 325, 350 | Green | 40-60 | 800 |
| Type3 -v2 | 18 | 1.25 | 22 | 0.70 | 200, 225, 250,<br>275, 300, 325, 350 | Black | 40-60 | 800 |
| Type3 -v3 | 18 | 1.20 | 23 | 0.63 | 200, 225, 250,<br>275, 300, 325, 350 | Light blue | 40-60 | 800 |

#### 7. Intended Use

The Kitazato OPU Needles consisting of:

- Kitazato OPU Needle with Connection Tube, model number Type 2
- . Kitazato OPU Reduced Needle, model number Type 3

are intended to obtain oocytes from ovarian follicles.

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K112462
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### 8. Substantial Equivalence Discussion

The indication for use and technology of the OPU Needle are substantially equivalent to the identified predicate devices.

#### 9. Non-Clinical Testing

The needle mechanical tensile testing and mouse embryo testing results supports that all the specifications have met the acceptance criteria for the device. The Kitazato OPU Needles passed all testing and supports the claims of substantial equivalence.

- . Mechanical Tensile Testing: Tensile strength to withstand 22N for needle tube O.D. <0.55 mm
- . Bending Elasticity Testing: Return normal position after bending 8° from straight for needle tube O.D. ≤1.0 mm
- Folding Strength Testing: No fracture of needle tube is detected when needle tube . of O.D. ≤1.0 mm and length ≥12mm is folded to 90°
- Dimensional Testing: Passes outer diameter and length according to specifications .
- Endotoxin Testing: Endotoxin values conform to the value ≤20 EU/device �
- Sterility Testing: No microbial growth from sterility testing .
- t Mouse Embryo Assay: ≥80% expanded to blastocyst stage within 96 hours

The Kitazato OPU Needles were tested and complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

#### 10. Conclusion

:

The Kitazato OPU Needles are substantially equivalent to its proposed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 26, 2012

KITAZATO Medical Co., Ltd. % Richard Vincins, CQA, CBA, RAC (US,EU) Vice President, Quality Assurance Emergo Group 611 West 5th Street, Third Floor AUSTIN TX 78701

Re: K112462

Trade/Device Name: Kitazato OPU Needle Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted reproduction needles Regulatory Class: II Product Code: MQE Dated: November 6, 2012 Received: November 15, 2012

Dear Mr. Vincins:

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.

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## Page 2 - Richard Vincins, CQA, CBA, RAC(US,EU)

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.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert R. Lerner

-Acting Director 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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# Section 4 - Indications for Use Statement

#### 510(k) Number (if known): K112462

Device Name: Kitazato OPU Needle

#### Indications for Use:

The Kitazato OPU Needles consisting of:

- Kitazato OPU Needle with Connection Tube, model number Type 2 .

| Model | Color of Hub | Needle O.D. (mm) | Needle Gauge | Needle Length (mm) | Connection Tube Length (mm) |
|-----------|--------------|------------------|--------------|-----------------------------------|-------------------------------|
| Type2 -v1 | White | 1.65 | 16 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v2 | Light brown | 1.49 | 17 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v3 | Pink | 1.25 | 18 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v4 | Ivory | 1.06 | 19 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v5 | Yellow | 0.90 | 20 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v6 | Green | 0.80 | 21 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v7 | Black | 0.70 | 22 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v8 | Light blue | 0.63 | 23 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v9 | Purple | 0.55 | 24 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |

- Kitazato OPU Reduced Needle, model number Type 3 .

| Model | Needle<br>Gauge | Needle<br>O.D.<br>(mm) | Narrow<br>Tip<br>Gauge | Narrow<br>Tip O.D.<br>(mm) | Needle Length<br>(mm) | Color of<br>Hub | Length of<br>Reduced<br>Needle<br>(mm) | Connection<br>Tube Length<br>(mm) |
|-----------|-----------------|------------------------|------------------------|----------------------------|--------------------------------------|-----------------|----------------------------------------|-----------------------------------|
| Type3 -v1 | 18 | 1.25 | 21 | 0.80 | 200, 225, 250, 275,<br>300, 325, 350 | Green | 40-60 | 800 |
| Type3 -v2 | 18 | 1.25 | 22 | 0.70 | 200, 225, 250, 275,<br>300, 325, 350 | Black | 40-60 | 800 |
| Type3 -v3 | 18 | 1.20 | 23 | 0.63 | 200, 225, 250, 275,<br>300, 325, 350 | Light blue | 40-60 | 800 |

are intended to obtain oocytes from ovarian follicles.

Prescription Use ____________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _____________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner

Acting Director for Benjamin R. Fisher, Ph.D.

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K112462 510/k) Numhar