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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Narishige IM-11 Pneumatic Microinjector. It focuses on establishing substantial equivalence to a predicate device, the IM-9C Pneumatic Injector, rather than presenting a study demonstrating the device meets specific acceptance criteria for performance.

Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided document. The document primarily relies on a comparison of technological characteristics and intended use to claim substantial equivalence.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document does not define specific quantitative acceptance criteria for the IM-11. Instead, it compares the IM-11's technological characteristics to those of its predicate device, the IM-9C, implying that performance is acceptable if these characteristics are similar or improved.

Feature / Characteristic	Acceptance Criteria (Implicit)	IM-11 Pneumatic Microinjector (Subject Device) Performance	IM-9C Pneumatic Injector (Predicate Device) Performance
Maximum Operating Range	Similar to or better than predicate device	40mm (coarse and fine combined) 30mm by Coarse Control Knob 17mm by Fine Control Knob	53mm
Distance Plunger Travels & Volume Controlled by One Rotation	Similar to predicate device performance	Coarse Control Knob: Approx. 6.0mm and 1ml (theoretical) Fine Control Knob: Approx. 1.4mm and 250ul (theoretical)	Approx. 6.0mm and 480ul
Pressure Relief Valve	Functional pressure release mechanism	Lever-activated pressure relief valve	Valve plug on tube connector
Syringe Volume	Functional for intended use	7,900ul	4,240ul
Dimensions	Suitable for intended use	167-214(W)x55(D)x78(H)mm	136-189(W)x55(D)x74(H)mm
Weight	Suitable for intended use	680g	640g
Intended Use	Same as predicate for core functions	Aspirate/inject sperm into oocytes, hold oocytes during ICSI	Inject solutions, aspirate fluids, hold cells/eggs

Note: The IM-11's maximum operating range (40mm) is less than the IM-9C (53mm), but this is not presented as a deficiency, likely because the combined coarse and fine controls offer sufficient precision and range for ICSI procedures. The larger syringe volume and the more convenient pressure relief valve (lever vs. plug) are presented as improvements or at least not negatively impacting safety/effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

Not applicable/Not provided. This document does not describe a clinical study with a test set of data. The assessment is based on a technical comparison of the device itself and its predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable/Not provided. No "test set" or "ground truth" using human experts is described in this document.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set or expert adjudication is described.

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

Not applicable. This device is a pneumatic microinjector, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

Not applicable. This is a mechanical device, not an algorithm. Therefore, a standalone algorithm performance study is irrelevant.

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

Not applicable. The submission does not define a "ground truth" as it would for a diagnostic or AI device. Instead, the "truth" is established by comparing the technological characteristics and documented performance/safety of the predicate device.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is a medical device for physical manipulation, not an AI/algorithm.

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

Not applicable. There is no training set mentioned.

Summary

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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: 81-3-3308-8383 Fax: 81-3-3308-8700 E-mail: sales@narishige.co.jp

Date Submitted: November 30, 2011

Device Identification:

Trade Name:	IM-11 Pneumatic Microinjector
Common Name:	Injector
Classification Name:	Assisted Reproduction Micromanipulators and Microinjectors(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 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 PneumaticMicroinjector (Subject Device)	IM-9C Pneumatic Injector(Predicate Device)
MaximumOperatingRange	40mm (coarse and fine combined)30mm by Coarse Control Knob17mm by Fine Control Knob	53mm
Distance thePlunger travelsand Volumecontrolled byOne Rotationof ControlKnob	Approximately 6.0mm and 1ml (theoretical value) for Coarse Control Knob.Approximately 1.4mm and 250ul (theoretical value) for Fine Control Knob.	Approximately 6.0mm and 480ul
Pressure ReliefValve	Pressure Relief Valve:Function: Allows pressure to escape and neutralizes the pressure inside the Microinjector.How to Use: Simply press the lever on the Pressure Relief Valve.	Tube Connector (with Multipurpose Valve):Function: Allows pressure to escape and neutralizes the pressure inside the Injector.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

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

Page 1 of _1

Regulation Number and Section

§ 884.6150 Assisted reproduction micromanipulators and microinjectors.

(a)
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.(b)
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.