(165 days)
Not Found
No
The device description details a motorized micromanipulator and manual microinjectors controlled by a joystick and piston system, respectively. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on hardware and software testing, not AI/ML model validation.
Yes
The devices (micromanipulator and microinjectors) are intended for use in assisted reproduction procedures (ICSI, IVF), directly manipulating oocytes and sperm for therapeutic purposes (e.g., to achieve pregnancy). These procedures involve physical intervention on biological material to treat a medical condition (infertility).
No
The device description indicates that the TransferMan® 4m Micromanipulator and CellTram® Microinjectors are used for precise manipulation and injection of cells in assisted reproduction procedures (ICSI, IVF), which are interventional procedures rather than diagnostic ones.
No
The device description explicitly details hardware components such as a Motor module unit, Control board, Universal Capillary Holder, and manual piston pumps (CellTram Microinjectors). The performance studies also mention hardware testing.
Based on the provided information, the TransferMan® 4m Micromanipulator and the CellTram® Microinjectors are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The descriptions clearly state that these devices are used for manipulating and injecting cells (sperm and oocytes) in assisted reproduction procedures (ICSI and IVF). They are tools for physically handling biological material, not for analyzing or testing it to diagnose a condition.
- Intended Use: The intended uses focus on the mechanical manipulation and transfer of cells for fertilization, not on diagnostic testing.
Therefore, while they are used in a process that ultimately relates to human health (reproduction), their function is not that of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TransferMan® 4m Micromanipulator Indications for Use:
The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.
CellTram® Air Microinjector / CellTram® Oil Microinjector / CellTrans® vario Microinjector Indications for Use: The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.
Product codes (comma separated list FDA assigned to the subject device)
MQJ
Device Description
The TransferMan® 4m Micromanipulator is a motorized micromanipulator consisting of a Motor module unit and a Control board that allows the user to precisely control the movement of tools (i.e., microcapillaries) used for Intra-Cytoplasmic Spermatozoa Injection (ICSI) and other In Vitro Fertilization (IVF) procedures. The tool is mounted in a Universal Capillary Holder on the TransferMan® 4m Micromanipulator's Motor module unit that is, itself, mounted to an inverted microscope. The user controls the movements of the tool using a joystick on the Control board. The Motor module unit shifts the position of the tool in response to the joystick motions.
The CellTram Microinjectors are manual piston pumps for holding and transfer of suspension cells (e.g., oocytes and sperms for use in ICSI procedures), used in manual microinjection procedures. Using a movable piston in a cylinder system, the CellTram® Microinjectors generate differences in pressure that are transferred directly to a microcapillary via a connected pressure tube. Depending on the piston movement, material can be aspirated or dispensed. Three versions of the CellTram® Microinjectors will be marketed for use in ICSI procedures, the CellTram® Air, the CellTram® Oil, and the CellTram vario. The three versions differ in the medium used for pressure transmission (air versus oil).
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)
The safety and effectiveness of the proposed TransferMan® 4m Micromanipulator has been confirmed by hardware and software testing. The proposed micromanipulator complies with applicable requirements of the following standards:
- EN 61326- 1:2006, "Electrical Equipment for Measurement, Control and Laboratory .
Use - EMC Requirements" - . EN 55011:2011, "Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Radio Disturbance Characteristics - Limits And Methods Of Measurement"
- EN 61000-4-2:2009-12, Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques - Section 2: Electrostatic discharge immunity test
- EN 61000-4-3:2011-04, "Electromagnetic compatibility (EMC) Part 4-3: Testing . and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test"
- EN 61000-4-4:2013-04, "Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques - Section 4: Electrical fast transient/burst immunity test"
- EN 61000-4-5:2007-06, "Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques – Section 5: Surge immunity test"
- EN 61000-4-6:2009-12, "Electromagnetic compatibility (EMC) Part 4: Testing and . measurement techniques – Section 6: Immunity to conducted disturbances, induced by radio-frequency fields"
- EN 61000-4-11:2005-02, "Electromagnetic compatibility (EMC) Part 4: Testing and . measuring techniques - Section 11: Voltage dips, short interruptions and voltage variations immunity tests"
- UL 61010-1 Edition 2:2008/10/28, "Electrical Equipment For Measurement, Control, . and Laboratory Use; Part 1: General Requirements''
The safety and effectiveness of the proposed CellTram® Microinjectors has been confirmed by hardware testing. The proposed CellTram® Microinjectors underwent endurance testing. Packaging validation testing has been performed according to ASTM D4169-09, "Standard Practice for Performance Testing of Shipping Containers and Systems".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Eppendorf AG % JoAnne Bronikowski Regulatory Services Senior Project Manager Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752
Re: K142207
Trade/Device Name: TransferMan® 4m Micromanipulator CellTram® Air Microinjector CellTram® Oil Microinjector CellTram® vario Microinjector Regulation Number: 21 CFR 884.6150 Regulation Name: Assisted reproduction micromanipulators and microinjectors Regulatory Class: Class II Product Code: MQJ Dated: December 17, 2014 Received: January 23, 2015
Dear JoAnne Bronikowski,
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
1
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known) K142207
Device Name
TransferMan® 4m Micromanipulator, CellTram® Air Microinjector, CellTram® Vario Microinjector
Indications for Use (Describe)
TransferMan® 4m Micromanipulator Indications for Use:
The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.
CellTram® Air Microinjector / CellTram® Oil Microinjector / CellTrans® vario Microinjector Indications for Use: The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | lebrand |
|---|---|
| ------------------------------------------------------------------------------ | --------- |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (101) 443-6740
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510(k) Summary for the Eppendorf AG
TransferMan® 4m Micromanipulator and CellTram® Microinjectors (per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
1. SUBMITTER/510(K) HOLDER
Eppendorf AG Barkhausenweg 1 22339 Hamburg Germany Phone: +49 40 53801 - 188 Establishment Registration No: 801047
Contact: Dr. Cornelia Hildebrandt, Global Product Line Manager Cell Handling Contact's Phone: +49 40 53801 - 188 Contact's Email: hildebrandt.c@eppendorf.de Date Prepared: July 28, 2014
2. DEVICE NAME
| Trade Name: | TransferMan ® 4m Micromanipulator
CellTram ® Air Microinjector
CellTram ® Oil Microinjector
CellTram ® vario Microinjector |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Micromanipulator and microinjectors |
| Device Name: | Assisted reproduction micromanipulators and microinjectors |
| Classification Panel: | Obstetrics/Gynecology Devices |
| Classification Number: | 884.6150 |
| Product Code: | MQJ |
3. PREDICATE DEVICES
The proposed TransferMan® 4m Micromanipulator and CellTram Microinjectors are substantially equivalent to other legally marketed assisted reproduction micromanipulators and microinjectors including the following:
- IM-11 Pneumatic Microinjector (Narishige Co., Ltd., K113712) ●
- NAI-5 Micromanipulator Set (Narishige Co., Ltd., K120877)* ●
- Eppendorf is claiming substantial equivalence of the proposed TransferMan® 4m Micromanipulator only to the Micromanipulator, not to the NAI-5 Micromanipulator Set as a whole.
A comparison of the intended use and features of the proposed TransferMan® 4m Micromanipulator and CellTram Microinjectors and the predicate devices described in K113712 and K120877 is provided in Table 5-1.
4
4. DEVICE DESCRIPTION
The TransferMan® 4m Micromanipulator is a motorized micromanipulator consisting of a Motor module unit and a Control board that allows the user to precisely control the movement of tools (i.e., microcapillaries) used for Intra-Cytoplasmic Spermatozoa Injection (ICSI) and other In Vitro Fertilization (IVF) procedures. The tool is mounted in a Universal Capillary Holder on the TransferMan® 4m Micromanipulator's Motor module unit that is, itself, mounted to an inverted microscope. The user controls the movements of the tool using a joystick on the Control board. The Motor module unit shifts the position of the tool in response to the joystick motions.
The CellTram Microinjectors are manual piston pumps for holding and transfer of suspension cells (e.g., oocytes and sperms for use in ICSI procedures), used in manual microinjection procedures. Using a movable piston in a cylinder system, the CellTram® Microinjectors generate differences in pressure that are transferred directly to a microcapillary via a connected pressure tube. Depending on the piston movement, material can be aspirated or dispensed. Three versions of the CellTram® Microinjectors will be marketed for use in ICSI procedures, the CellTram® Air, the CellTram® Oil, and the CellTram vario. The three versions differ in the medium used for pressure transmission (air versus oil).
5. INDICATIONS FOR USE
The TransferMan 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.
The CellTram Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
Both the proposed TransferMan® 4m Micromanipulator and the predicate NAI-5 Micromanipulator are motor-driven micromanipulators that allow the user to control the movement of a tool using the joystick on the Control unit. Motors in the Motor module unit shift the position of the tool in response to the joystick motions in X, Y, and Z directions. The manufacturers of both the proposed and predicate devices provide adapters for attaching the Motor module unit to inverted microscopes commonly used for assisted reproduction procedures. The proposed TransferMan® 4m Micromanipulator and predicate NAI-5 Micromanipulator are indicated for coarse and fine tool positioning.
The CellTram Microinjectors and the predicate IM-11 Pneumatic Microinjector are used
5
to control aspiration of the sperm into the microcapillary, and after perforation of the oocyte to release of the sperm into the ooplasm. Both the proposed and predicate devices consist of manually controlled pistons that slide within a cylinder system in and out to aspirate or dispense. The CellTram Air, the CellTram® Oil, and the CellTram® vario have different mediums used for pressure transmission (air versus oil). The predicate IM-11 Pneumatic Microinjector operates using air only.
The manufacturer believes that the technological characteristics of the TransferMan 4m Micromanipulator and the CellTram Microinjectors are substantially equivalent to those of the predicate devices.
The tables below provide the comparison of the characteristics between the proposed and predicated devices.
| | Feature | TransferMan® 4m
Micromanipulator Eppendorf AG
(Proposed) | NAI-5 Micromanipulator Set
Narishige Col. Ltd System
(K120877) |
|--------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| General | Intended Use | Intended for use in assisted
reproduction procedures requiring
coarse and fine positioning of a
microtool under the microscope. | : "… enables course and fine
positioning of a microtool under the
microscope and is used in assisted
reproduction procedures." |
| | Components | Motor Module
Control Board | Drive Unit
2 Control Units for coarse and fine
Power Supply |
| | Power Supply | Input: 120-240 V AC; 50-60 Hz | Input: 100-240 V; 50 Hz |
| | Range of movement | Coarse: $5 \mu m$ to $12,500 \mu m$ in $5 \mu m$
increments
Fine: $5 \mu m$ to $2,000 \mu m$ in $5 \mu m$
increments
X-Fine: $1 \mu m$ to $600 \mu m$ in $1 \mu m$
increments | Coarse: 22mm
Fine: 10mm
Increments not known |
| | Speed | 0 - 10,000 µm/s | Max. 1.4 mm/s |
| | Step Motors | X-,Y-,Z- Module | X-,Y-,Z- Module |
| | Step Size | 80 mm | Not known |
| | Dimensions | Module (X,Y,Z): 129 mm x 51 mm x
36 mm (W x D x H) | Drive Unit: 57 mm x 138 mm x
94 mm (W x D x H) |
| | Weight | Motor module (complete): 2.15 kg
Module (X,Y,Z): 570g | Not known |
| | Maximum Traveling
Distance | 20 mm | Coarse: 22mm
Fine: 10mm |
| | Swivel Joint
Direction of
Rotation | -45° - +90° | Not known |
| | | | |
Side-by-Side Comparison of the TransferMan® 4m Micromanipulator with the NAI-5 Micromanipulator
6
| | Feature | TransferMan® 4m
Micromanipulator Eppendorf AG
(Proposed) | NAI-5 Micromanipulator Set
Narishige Col. Ltd System
(K120877) |
|--------------|-------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------|
| Control Unit | Capillary Exchange | Direction of rotation: forward (swivel out) | |
| | Sample Replacement | Direction of rotation: backward (swivel in) | |
| | Operating Angle of Angle Head | 0° - 90° | |
| | Microscope Compatibility | All major microscope brands: Leica, Nikon, Olympus, and Zeiss | All major microscope brands: Leica, Nikon, Olympus, and Zeiss |
| | Dimensions | 205 mm x 288 mm x 152 mm (W x D x H) | 70 mm x 100 mm x 120 mm (W x D x H) |
| | Weight | Control board: 1.8 kg (includes mains/power supply device) | Not known |
| | Control Mechanism | Dual Speed joystick | Joystick |
| | Working range | Coarse, fine, x-fine | Coarse, fine |
| | Programmable | Yes | No |
| | External device/PC Connection | Serial interface SubD9, male | Not known |
| | Speed Control | Proportional and dynamic kinetics | |
Side-by-Side Comparison of the CellTram® Microinjectors with the IM-11 Pneumatic Microinjector
| | Feature | CellTram® Microinjectors
Eppendorf AG
(Proposed) | IM-11 Pneumatic Microinjector
Narishige Co., Ltd.
(K113712) |
|---------------------------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Intended Use | Intended for use in Intra-Cytoplasmic
Spermatozoa Injection (ICSI)
procedures to aspirate and inject
sperm into oocytes. | Intended for use for Intra-
Cytoplasmic Sperm Injection (ICSI)
procedures to aspirate and inject
sperm into oocytes, and to hold
oocytes during the ICSI procedure |
| | Microinjector Type | CellTram® Air (air transfer medium)
CellTram® Oil (oil transfer medium)
CellTram® vario (oil transfer medium,
coarse/fine adjustment) | Air transfer medium |
| | Operation | Manual microinjection | Manual microinjection |
| | Minimum
Adjustment Volume |