(89 days)
No
The description focuses on motor-driven and oil hydraulic mechanisms for positioning, with no mention of AI, ML, or image processing.
No
The device is described as a micromanipulator that enables positioning of a microtool for use in assisted reproduction procedures; it is not described as directly treating a condition or disease.
No
Explanation: The device is described as a micromanipulator used for positioning a microtool in assisted reproduction procedures. Its function is to manipulate tools, not to diagnose conditions or diseases.
No
The device description explicitly states it consists of "motor driven coarse manipulators" and "oil hydraulic micromanipulators," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as enabling the positioning of a microtool under a microscope for use in assisted reproduction procedures. This is a mechanical manipulation of a tool, not a test performed on a biological sample in vitro (outside the body) to diagnose a condition or provide information about a physiological state.
- Device Description: The description reinforces the mechanical nature of the device, detailing motor-driven and oil hydraulic components for positioning.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
The device is a tool used during a procedure, not a test performed on a sample.
N/A
Intended Use / Indications for Use
The NAI-5 Micromanipulator Set is used for coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.
Product codes
MQJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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:
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.
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 | |
|---|---|---|---|
| Micromanipulator | |||
| Set | Motor-drive | ||
| Manipulator | Three-axis | ||
| Hanging Joystick | |||
| Oil Hydraulic | |||
| Micromanipulator | |||
| 510(k) Status and | |||
| number | Subject Device | Predicate Device | Predicate Device |
| K002291 | K002659 | ||
| Type of | |||
| manipulator | Coarse and fine | Coarse only | Fine only |
| Type of control | Motorized and Oil | ||
| Hydraulic control | Motorized control | Oil Hydraulic | |
| control | |||
| Configuration | Coarse and Fine | ||
| Drive Units, | |||
| Coarse and Fine | |||
| Control Units, and | |||
| Power Supply | Coarse Drive | ||
| Unit, Coarse | |||
| Control Unit, and | |||
| Power Supply | Fine Drive Unit, | ||
| and Fine Control | |||
| Unit | |||
| Identification of | |||
| each axis | X-axis, Y-axis, and | ||
| Z-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)
| Movement
Range of
each axis | Coarse: 22mm
Fine: 10mm | Coarse: 22mm | Fine: 10mm |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions
of Drive Unit | W57 x D138 x
H94mm
(Coarse and fine
combined) | W80 x D116 X
H142mm | W40 x D46 x
H87mm |
| Dimensions
of Motorized
Control Unit | W70 x D100 x H120mm | | N/A |
| Dimensions
of Hydraulic
Control Unit | W65 x D180 x
H175mm | N/A | W165 x D80 x
H175mm |
| Dimensions
of Power
Supply | W125 x D105 x H85mm | | N/A |
| 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. | The MM-89
Motor-drive
Manipulator helps
coarse positioning
of a microtool
under the
microscope and is
used in assisted
reproduction
procedures. | The MMO-202ND
Three-axis
Hanging Joystick
Oil Hydraulic
Micromanipulator
helps fine
positioning of a
microtool under the
microscope and is
used in assisted
reproduction
procedures. |
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)
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