The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.

Device Description

The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures. The NAI-5 Micromanipulator Set consists of motor driven coarse manipulators that enable coarse movement operation and oil hydraulic micromanipulators that enable fine movement operation.

AI/ML Overview

The provided document is a 510(k) summary for the NAI-5 Micromanipulator Set. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific, quantifiable clinical performance acceptance criteria with a dedicated study involving human subjects or AI algorithms.

Therefore, many of the requested categories regarding acceptance criteria, study design, expert involvement, and comparative effectiveness (which are more relevant to AI/diagnostic device approvals) are not applicable to this 510(k) notification for a micromanipulator set.

However, I can extract the information that is present and indicate where requested information is not available or not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this micromanipulator set, "acceptance criteria" are embodied by the technical specifications and intended use being substantially equivalent to the predicate devices. There are no explicit, quantifiable clinical performance metrics or thresholds defined as "acceptance criteria" in the context of a clinical study in this document. The "performance" is demonstrated by the device's physical and functional specifications.

Characteristic	Acceptance Criteria (Predicate Device Specifications)	Reported Device Performance (NAI-5 Micromanipulator Set)
Type of manipulator	Coarse only (MM-89) AND Fine only (MMO-202ND)	Coarse and fine
Type of control	Motorized control (MM-89) AND Oil Hydraulic control (MMO-202ND)	Motorized and Oil Hydraulic control
Configuration	Coarse Drive Unit, Coarse Control Unit, Power Supply (MM-89) AND Fine Drive Unit, Fine Control Unit (MMO-202ND)	Coarse and Fine Drive Units, Coarse and Fine Control Units, and Power Supply
Identification of each axis	X-axis, Y-axis, and Z-axis (coarse only for MM-89; fine only for MMO-202ND)	X-axis, Y-axis, and Z-axis (coarse and fine)
Movement Range of each axis	Coarse: 22mm (MM-89) AND Fine: 10mm (MMO-202ND)	Coarse: 22mm; Fine: 10mm
Dimensions of Drive Unit	W80 x D116 x H142mm (MM-89) AND W40 x D46 x H87mm (MMO-202ND)	W57 x D138 x H94mm (Coarse and fine combined)
Dimensions of Motorized Control Unit	W70 x D100 x H120mm (MM-89)	W70 x D100 x H120mm
Dimensions of Hydraulic Control Unit	W165 x D80 x H175mm (MMO-202ND)	W65 x D180 x H175mm
Dimensions of Power Supply	W125 x D105 x H85mm (MM-89)	W125 x D105 x H85mm
Intended Use	Helps coarse positioning of a microtool under the microscope and is used in assisted reproduction procedures (MM-89) AND Helps fine positioning of a microtool under the microscope and is used in assisted reproduction procedures (MMO-202ND)	Enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.

2. Sample size used for the test set and the data provenance

Not Applicable. This device is a physical micromanipulator. A 510(k) submission for this type of device typically relies on engineering specifications, bench testing, and comparison to predicate devices, rather than a "test set" of clinical data or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth for a "test set" of clinical data was established for this device, as it's a physical instrument and not an AI or diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or associated adjudication methods are described for this physical device.

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 is a physical laboratory instrument, not an AI-assisted diagnostic or imaging system involving "human readers" or AI assistance.

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

Not Applicable. This device is a physical micromanipulator; there is no standalone algorithm to evaluate.

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

Not Applicable. As a physical instrument, the "ground truth" for its function relies on its engineering specifications and the ability to perform its mechanical tasks accurately, which would be verified through bench testing and quality control during manufacturing, not through clinical ground truth data like pathology or outcomes.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is a physical device, not an AI algorithm.

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

Not Applicable. There is no training set for this device.

Summary

{0}------------------------------------------------

JUN 20 2012

K12087

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

Submitted by:

Mrs. Mitsuko Yoneyama President

Narishige Co., Ltd. 27-9, Minamikarasuvama 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: March 19, 2012

Device Identification:

Trade Name: NAI-5 Micromanipulator Set Common Name: Micromanipulator Set Classification Name: Assisted Reproduction Micromanipulators and Microinjectors (21 CFR. 884.6150)

Predicate Device:

Narishige Co., Ltd. claims the NAI-5 Micromanipulator Set as substantially equivalent to a system that has combined two predicate devices: MM-89 Motor drive Manipulator (Premarket Notification 510(k) Number: K002291) and MMO202ND Three axis Hanging Joystick Oil Hydraulic Micromanipulator (Premarket Notification 510(k) Number: K002659).

Device Description:

Intended Use:

The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.

{1}------------------------------------------------

Technological Characteristics:

The NAI-5 Micromanipulator Set consists of motor driven coarse manipulators that enable coarse movement operation and oil hydraulic micromanipulators that enable fine movement operation.

The specifications of the NAI-5 are summarized in the comparison table below.

NAI-5	MM-89	MMO-202ND
MicromanipulatorSet	Motor-driveManipulator	Three-axisHanging JoystickOil HydraulicMicromanipulator
510(k) Status andnumber	Subject Device	Predicate Device	Predicate Device
	K002291	K002659
Type ofmanipulator	Coarse and fine	Coarse only	Fine only
Type of control	Motorized and OilHydraulic control	Motorized control	Oil Hydrauliccontrol
Configuration	Coarse and FineDrive Units,Coarse and FineControl Units, andPower Supply	Coarse DriveUnit, CoarseControl Unit, andPower Supply	Fine Drive Unit,and Fine ControlUnit
Identification ofeach axis	X-axis, Y-axis, andZ-axis	X-axis, Y-axis,and Z-axis	X-axis, Y-axis,and Z-axis
	(coarse and fine)	(coarse only)	(fine only)

Comparison Table

(The table is continued to the next page.)

{2}------------------------------------------------

(NAI-5)

(MM-89)

(MMO-202ND)

MovementRange ofeach axis	Coarse: 22mmFine: 10mm	Coarse: 22mm	Fine: 10mm
Dimensionsof Drive Unit	W57 x D138 xH94mm(Coarse and finecombined)	W80 x D116 XH142mm	W40 x D46 xH87mm
Dimensionsof MotorizedControl Unit	W70 x D100 x H120mm		N/A
Dimensionsof HydraulicControl Unit	W65 x D180 xH175mm	N/A	W165 x D80 xH175mm
Dimensionsof PowerSupply	W125 x D105 x H85mm		N/A
Intended Use	The NAI-5MicromanipulatorSet enables coarseand fine positioningof a microtool underthe microscope andis used in assistedreproductionprocedures.	The MM-89Motor-driveManipulator helpscoarse positioningof a microtoolunder themicroscope and isused in assistedreproductionprocedures.	The MMO-202NDThree-axisHanging JoystickOil HydraulicMicromanipulatorhelps finepositioning of amicrotool under themicroscope and isused in assistedreproductionprocedures.

Substantial Equivalence:

Narishige Co., Ltd. claims the NAI-5 Micromanipulator Set as substantially equivalent to a system that has combined two predicate devices: MM 89 Motor drive Manipulator (Premarket Notification 510(k) Number: K002291) and MMO 202ND Three-axis Hanging Joystick Oil Hydraulic Micromanipulator (Premarket Notification 510(k) Number: K002659).

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

Re: K120877

Trade/Device Name: NAI-5 Micromanipulator Set Regulation Number: 21 CFR§ 884.6150 Regulation Name: Assisted reproduction micromanipulators and microinjectors Regulatory Class: II Product Code: MQJ Dated: March 23, 2012 Received: March 23, 2012

JUN 2 0 2012

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 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

{4}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély vours,

and an

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

{5}------------------------------------------------

4. Indications for Use:

510(k) Number (if known): K120877

Device Name: NAI-5 Micromanipulator Set

The NAI-5 Micromanipulator Set is used for coarse and fine Indications for Use: positioning of a microtool under the microscope and is used in assisted reproduction procedures.

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)

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.