(87 days)
Not Found
No
The description explicitly states the device is "manually operated" and controlled by "coarse and fine control knobs," with no mention of automated decision-making, learning, or data processing that would indicate AI/ML.
No
The device is used to aspire and inject sperm into oocytes and hold oocytes during the ICSI procedure, which is a laboratory procedure, not a therapeutic treatment for a patient.
No
The device is used for intracytoplasmic sperm injection (ICSI) procedures to manipulate sperm and oocytes via aspiration, injection, and holding. It does not provide any diagnostic information about the patient's health or condition.
No
The device description explicitly states it is a "manually operated pneumatically actuated screw driven microinjector incorporating coarse and fine control knobs," indicating it is a physical hardware device.
Based on the provided information, the IM-11 Pneumatic Microinjector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- The IM-11 Pneumatic Microinjector is used for a procedure (ICSI) that directly manipulates biological material (sperm and oocytes) for reproductive purposes. It's a tool used in a clinical procedure, not a diagnostic test.
- The intended use describes a procedure (aspirating and injecting sperm, holding oocytes), not a diagnostic test.
Therefore, the IM-11 Pneumatic Microinjector falls under the category of a medical device used in a clinical procedure, not an IVD.
N/A
Intended Use / 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.
Product codes
MQJ
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.
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
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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 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.
1
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.
2
| Comparison Table | ||
|---|---|---|
| IM-11 Pneumatic | ||
| Microinjector (Subject Device) | IM-9C Pneumatic Injector | |
| (Predicate Device) | ||
| Maximum | ||
| Operating | ||
| Range | 40mm (coarse and fine combined) | |
| 30mm by Coarse Control Knob | ||
| 17mm by Fine Control Knob | 53mm | |
| Distance the | ||
| Plunger travels | ||
| and Volume | ||
| controlled by | ||
| One Rotation | ||
| of Control | ||
| Knob | 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 Relief | ||
| Valve | 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
4
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,
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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