IM-11 PNEUMATIC MICROINJECTOR

K113712 · Narishige Co., Ltd. · MQJ · Mar 15, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K113712
• Device Name: IM-11 PNEUMATIC MICROINJECTOR
• Applicant: Narishige Co., Ltd.
• Product Code: MQJ · Obstetrics/Gynecology
• Decision Date: Mar 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6150
• Device Class: Class 2

Indications for Use

The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.

Device Story

The IM-11 Pneumatic Microinjector is a manually operated, pneumatically actuated, screw-driven device used in assisted reproduction. It functions as a component of a micromanipulator system. The operator uses coarse and fine control knobs to manage pneumatic pressure for aspirating sperm into an injection pipette, injecting sperm into oocytes, and holding oocytes during ICSI procedures. Turning the knob clockwise performs injection, while counterclockwise rotation performs aspiration. It includes a pressure relief valve to neutralize internal pressure. The device is used in clinical settings by trained professionals to facilitate fertilization procedures, directly assisting the clinician in the precise manipulation of gametes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manually operated, pneumatically actuated, screw-driven injector. Features coarse and fine control knobs, metal syringe (7,900ul), and a pressure relief valve. Dimensions: 167-214(W)x55(D)x78(H)mm. Weight: 680g. Standalone mechanical device; no software or electronic components.

Indications for Use

Indicated for use in Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into oocytes and to hold oocytes.

Regulatory Classification

Identification

Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.

Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• IM-9C Pneumatic Injector (K001910)

Submission Summary (Full Text)

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# MAR 1 5 2012

#### 5. 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

Submitted by: Mrs. Mitsuko Yoneyama President

> Narishige Co., Ltd. 27-9, Minamikarasuyama 4 chome Setagaya-ku Tokyo 157-0062 Japan

Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date Submitted: November 30, 2011

#### Device Identification:

| Trade Name: | IM-11 Pneumatic Microinjector |
|----------------------|----------------------------------------------------------------------------------|
| Common Name: | Injector |
| Classification Name: | Assisted Reproduction Micromanipulators and Microinjectors<br>(21 CFR. 884.6150) |

#### Predicate Device:

Narishige Co., Ltd. claims the IM-11 Pneumatic Microinjector as substantially equivalent to predicate the IM 9C Pneumatic Injector, Premarket Notification 510(k) Number: K001910.

#### Device Description:

The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.

The IM-11 Pneumatic Microinjector is a manually operated pneumatically actuated screw driven microinjector incorporating coarse and fine control knobs. The coarse control knob is used to perform coarse movement operation while the fine control knob is used to perform fine movement operation. It is easy to use simply by turning the control knob clockwise for injection and counterclockwise for aspiration.

The IM-11 Pneumatic Microinjector is a component part of a micromanipulator system.

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Examples of roles the IM-11 plays in the ICSI would be

- holding an oocyte
- · aspirating a sperm into the injection pipette
- injecting a sperm into an oocyte

#### Intended Use:

The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.

### Substantial Equivalence:

Narishige Co., Ltd. claims the IM-11 Pneumatic Microinjector as substantially equivalent to predicate the IM-9C Pneumatic Injector, Premarket Notification 510(k) Number: K001910.

#### Technological Characteristics:

The IM-11 and the predicate device IM-9C (K001910) are both manually operated pneumatically actuated screw driven injectors. They are both a part of the micromanipulator system and can be used interchangeably.

Comparisons of the technological characteristics between the IM-11 and the predicate device IM-9C are summarized in the table on the next page.

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| Comparison Table | | |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IM-11 Pneumatic<br>Microinjector (Subject Device) | IM-9C Pneumatic Injector<br>(Predicate Device) |
| Maximum<br>Operating<br>Range | 40mm (coarse and fine combined)<br>30mm by Coarse Control Knob<br>17mm by Fine Control Knob | 53mm |
| Distance the<br>Plunger travels<br>and Volume<br>controlled by<br>One Rotation<br>of Control<br>Knob | Approximately 6.0mm and 1ml (theoretical value) for Coarse Control Knob.<br>Approximately 1.4mm and 250ul (theoretical value) for Fine Control Knob. | Approximately 6.0mm and 480ul |
| Pressure Relief<br>Valve | Pressure Relief Valve:<br>Function: Allows pressure to escape and neutralizes the pressure inside the Microinjector.<br>How to Use: Simply press the lever on the Pressure Relief Valve. | Tube Connector (with Multipurpose Valve):<br>Function: Allows pressure to escape and neutralizes the pressure inside the Injector.<br>How to Use: Loosen the Valve Plug on the Tube Connector. |
| Syringe | Metal Syringe: 7,900ul | Metal Syringe: 4,240ul |
| Dimensions | 167-214(W)x55(D)x78(H)mm | 136-189(W)x55(D)x74(H)mm |
| Weight | 680g | 640g |
| Intended Use | The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into oocytes, and to hold oocytes during the ICSI procedure. | The IM-9C Pneumatic Injector is used to inject solutions into organisms, aspirate fluid samples from tissues or hold cells and eggs by aspiration onto the end of a holding pipette. |

#### Conclusions:

Both the IM-11 and the IM-9C are manually operated pneumatically actuated screw driven injectors. They are made for the same purposes and share almost the same intended use. Narishige Co., Ltd. claims the IM-11 Pneumatic Microinjector is as safe, as effective, and performs as well as the legally marketed device: IM-9C Pneumatic Injector, Premarket Notification 510(k) Number: K001910.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The image is in black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Mrs. Mitsuko Yoneyama President Narishige Co., Ltd. 27-9. Minamikarasuyama 4-chome, Setagaya-ku TOKYO 157-0062 JAPAN

MAR 1 5 2012

Re: K113712

Trade/Device Name: IM-11 Pneumatic Microinjector Regulation Number: 21 CFR\$ 884.6150 Regulation Name: Assisted reproduction micromanipulators and microinjectors Regulatory Class: II Product Code: MQJ Dated: November 30, 2011 Received: December 19, 2011

Dear Mrs. Yoneyama:

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 I 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 or any I 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin K. Tarka

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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# 4. Indications for Use:

510(k) Number (if known): K113712

Device Name: IM-11 Pneumatic Microinjector

Indications for Use: The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.

| Prescription Use | V |
|-----------------------------|---|
| (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)

Tom M. Whing

1

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113712

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