(262 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the pipettes and the actuator, with no mention of AI or ML.
No.
The device is used for handling gametes and cells during assisted reproductive techniques and for removing cumulus from an oocyte, which are preparatory steps for fertilization, not direct therapeutic interventions.
No
Explanation: The EZ-Tip pipettes and EZ-Grip are used for handling gametes, embryos, and biopsied cells, and for denudation, during assisted reproductive techniques. They are tools for manipulation and processing, not for diagnosing a medical condition.
No
The device description clearly details physical components (polycarbonate capillary, aluminum barrel, stainless steel, PTFE, titanium, silicone, nylon) and their functions, indicating it is a hardware device.
Based on the provided information, the EZ-Tip pipettes and EZ-Grip device are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that the devices are for denudation, handling gametes, embryos, and biopsied cells during assisted reproductive techniques (ART). This is a procedural use, not a diagnostic one. They are used to manipulate biological materials, not to perform tests on them to diagnose a condition or determine a state of health.
- Device Description: The description details the physical characteristics and function of the pipettes and the grip for aspiration and expulsion. This aligns with tools used in laboratory procedures, not diagnostic assays.
- Performance Studies: The performance studies focus on the biocompatibility (MEA testing), sterility, endotoxin levels, packaging integrity, and device function (reprocessing validation, device life). These are relevant to the safety and performance of a medical device used in a procedure, but not to the analytical or clinical performance of a diagnostic test.
- Predicate Device: The predicate device, "The Stripper micropipet and micropipeter tips," is also a device used for manipulating cells in ART, not for diagnostic testing.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The EZ-Tip and EZ-Grip are tools used in a procedure (ART) to manipulate biological materials, not to perform a diagnostic test on those materials.
N/A
Intended Use / Indications for Use
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.
The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOH
Device Description
The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl.
Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:
- Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling
- Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation
The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable.
The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting.
The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.
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)
Non-Clinical Assessment of the EZ-Tip
- Mouse Embryo Assay (MEA) Testing: One-cell MEA testing was performed on three lots of EZ-Tip, demonstrating that devices met the acceptance specification of ≥80% hatched blastocysts at 120 h. Test articles passed all MEA testing conducted. MEA testing is performed on each lot of EZ-Tip.
- Endotoxin Testing: Bacterial Endotoxin (Limulus Amoebocyte Lysate) Assay testing (FDA recognized consensus standard USP "Bacterial Endotoxins Test" and ANSI/AAMI ST72:2011 "Bacterial endotoxins test methods, routine monitoring, and alternatives to batch testing") was performed on three lots of product demonstrating that devices met the acceptance specification of ≤20 EU/device. Endotoxin testing is performed on each lot of EZ-Tip.
- Sterilization Validation: The sterilization was performed in compliance with requirements in the applicable standards for gamma irradiation ISO11137-1:2006 "Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices" and ISO11137-2:2012 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose".
- Packaging Validation: Package integrity validation studies were conducted per ISO11607-2:2006 "Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes", ASTM F1886/F1886M - 09 "Standard Test Method for Seal Strength of Flexible Packaging by Visual Inspection", ASTM F1929-12 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" and ASTM F1140-07 "Standard Test Methods for Internal Pressurization Failure Resistance of the Unrestrained Packages." These studies used accelerated aged samples conditioned in accordance with ASTMF1980:07(2011) "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices".
- Shelf-Life: The proposed shelf-life of EZ-Tip Vial of 20 (three years) and Singles (five years) is supported by packaging and performance tests conducted on samples exposed to real-time and accelerated aging conditions pursuant to ASTMF1980:07(2011) "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices". The parameters assessed before and after aging included endotoxin (LAL) and MEA testing.
Non-Clinical Assessment of the EZ-Grip
- Mouse Embryo Assay (MEA) Testing: One-cell MEA testing was performed on three lots of EZ-Grip plunger wires demonstrating that devices met the acceptance specification of ≥80% hatched blastocysts at 120 h. Test articles passed all MEA testing conducted. MEA testing is performed on each lot of EZ-Grip plunger wires.
- Reprocessing Validation: Reprocessing validation of the EZ-Grip was in accordance with the procedures outlined in the FDA guidance document titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015.
- Device Life: Bench testing confirmed that the EZ-Grip performs according to the product specifications after routine maintenance and reprocessing during one year of simulated use consisting 16,000 actuations of the device set to aspirate 3 µl. Device evaluation consisted of measuring aspirated volume at each device setting, assessment of delivered volume and the force required to actuate the 3ul default setting and 1.4 µl blow-out function.
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
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
Research Instruments Ltd. Wendy Hassan Regulatory Affairs Executive Bickland Industrial Park Falmouth. Cornwall TR11 4TA United Kingdom
Re: K161275
Trade/Device Name: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: Class II Product Code: MOH Dated: December 14, 2016 Received: December 19, 2016
Dear Wendy Hassan,
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 device
1
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 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" (21 CFR 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,
Benjamin R. Fisher -S
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
Indications for Use
510(k) Number (if known) K161275
Device Name EZ-Tip Vial of 20 EZ-Tip Singles EZ-Grip
Indications for Use (Describe)
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.
The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.
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)
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3
Image /page/3/Picture/1 description: The image shows a stylized logo with the letters 'RI' in a bold, serif typeface. A curved line underlines the letters, adding a touch of elegance to the design. The logo is presented in black against a white background, creating a strong contrast.
Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 [International +44 1326 372 753] Fax: 01326 378783 [International +44 1326 378 783] e-mail: sales@research-instruments.com www.research-instruments.com
K161275 Page 1 of 5
510(k) Summary
Date prepared January 16, 2017
Submitter's information
Company Name: Registration Number: Address:
Telephone: Fax: Contact person: Contact Title: Contact email:
Device Names
Trade Name: Common name: Classification Number: Classification Name: Product Code: Classification Panel: Regulatory Class:
Predicate Device
Trade Name: Common name: Manufacturer: Classification Name: 510(K)
IVF micropipette and micropipetter 884.6130 Assisted Reproduction Microtools MQH (Microtools, Assisted Reproduction) Obstetrics/Gynecology ll
wendy.hassan@research-instruments.com
EZ-Tip Vial of 20, EZ-Tip Singles, EZ-Grip
Research Instruments Ltd.
Bickland Industrial Park
Cornwall TR11 4TA United Kingdom
+44 (0) 1326 372 753 +44 (0) 1326 378 783
Regulatory Affairs Executive
Wendy Hassan
9617095
Falmouth.
The Stripper micropipet and micropipeter tips IVF micropipet and micropipeter Mid-Atlantic Diagnostics, Inc Microtools, Assisted Reproduction (21CFR 884.6130, 85 MQH) Kaasaaa
The Stripper micopipet and micropipeter tips have not been subject to a design-related recall.
4
Image /page/4/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, stylized font. A curved line underlines the letters, adding a sense of elegance and movement to the design. The logo is simple, yet impactful, making it easily recognizable. The black color of the letters and line creates a strong contrast against the white background.
Device Description
The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl.
Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:
- Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling
- Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation
The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable.
The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting.
The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.
Indications for Use
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.
The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.
Comparison to Predicate Indication for Use
The Stripper tips indications for use is as follows:
- The Stripper micropipette family's indication for use is to manipulate and transfer zygotes and . embryos during IVF and ICSI procedures.
- · The Stripper micropipets are used in the tissue culture techniques performed by embryologists when preparing oocytes for IVF, ICSI and assisted hatching techniques prior to implantation.
- · The Stripper micropipets are tools used in procedures that have been developed to aid infertile couples achieve pregnancy
- . Removes cumulus and corona cells from oocytes for confirmation of fertility during IVF.
- Removes cumulus and corona cells from oocytes prior to ICSI procedures
- Used to transfer embryos and oocytes through various media and solutions during IVF procedures
Although differences in indications exist, the overall intended use is the same i.e. both subject and predicate devices are used to remove the cumulus and corona cells from occytes and to manipulate or handle human reproductive cells through various media and solutions during ART procedures.
The EZ-Grip is used in the same manner as intended by the Stripper predicate device i.e. to provide aspiration and expulsion capabilities to pipettes when fitted during assisted reproduction procedures.
5
Image /page/5/Picture/1 description: The image shows a logo with the letters "RI" in a bold, serif font. The letters are black and are positioned next to each other. Below the letters, there is a curved line that adds a decorative element to the logo. The overall design is simple and elegant.
K161275 Page 3 of 5
Technological Assessment
Table 1: Comparison of the EZ-Tip and the Stripper micropipette.
| Feature | EZ-Tip
K161275 | Stripper Tips
K993699 | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Geometry
and
dimensions | Proximal OD 0.9 mm
Distal ID size range -
75μm to 600 μm
Length 90 mm | Information unknown | Different: The specific
dimensions of tips clearec
in K993699 is not known;
however, differences in tip
dimensions do not raise
different safety and
effectiveness questions
(e.g., tip size appropriate
to handle reproductive
cells of interest). |
| Materials
used | Polycarbonate | Polycarbonate | Same |
| Manufacture | Extruded plastic capillary
Cut to provide different ID
dimensions
Sealed in packaging to
retain sterile barrier | Extruded plastic capillary
Cut to provide different ID
dimensions
Sealed in packaging to
retain sterile barrier | Same |
| Sterility | Sterile (SAL 10-6) gamma
irradiated | Sterile (SAL 10-6) gamma
irradiated | Same |
| Use | Single Use | Single Use | Same |
| Mouse
Embryo
Assay (MEA) | 1-Cell MEA: ≥80%
hatched blastocysts at
120 h. | 1-Cell MEA: ≥ 70%, to
blastocyst at 96 h | Different: The Mouse
Embryo Assay (MEA)
specification is lower in
the predicate device;
however this does not
raise different S & E
questions. |
| Endotoxin
(LAL) | "Bacterial Endotoxins Test" and ANSI/AAMI ST72:2011 "Bacterial endotoxins test methods, routine monitoring, and alternatives to batch testing") was performed on three lots of product demonstrating that devices met the acceptance specification of ≤20 EU/device. Endotoxin testing is performed on each lot of EZ-Tip.
- Sterilization Validation The sterilization was performed in compliance with . requirements in the applicable standards for gamma irradiation ISO11137-1:2006 "Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices" and ISO11137-2:2012 "Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose".
- · Packaging Validation Package integrity validation studies were conducted per ISO11607-2:2006 "Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes", ASTM F1886/F1886M - 09 "Standard Test Method for Seal Strength of Flexible Packaging by Visual Inspection", ASTM F1929-12 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" and ASTM F1140-07 "Standard Test Methods for Internal Pressurization Failure Resistance of the Unrestrained Packages." These studies used accelerated aged samples conditioned in accordance with ASTMF1980:07(2011) "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices".
- Shelf-Life The proposed shelf-life of EZ-Tip Vial of 20 (three years) and Singles (five years) is . supported by packaging and performance tests conducted on samples exposed to real-time and accelerated aging conditions pursuant to ASTMF1980:07(2011) "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices". The parameters assessed before and after aging included endotoxin (LAL) and MEA testing.
Non-Clinical Assessment of the EZ-Grip
- · Mouse Embryo Assay (MEA) Testing One-cell MEA testing was performed on three lots of EZ-Grip plunger wires demonstrating that devices met the acceptance specification of ≥80% hatched blastocysts at 120 h. Test articles passed all MEA testing conducted. MEA testing is performed on each lot of EZ-Grip plunger wires.
- Reprocessing Validation Reprocessing validation of the EZ-Grip was in accordance with the procedures outlined in the FDA guidance document titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015.
- · Device Life Bench testing confirmed that the EZ-Grip performs according to the product specifications after routine maintenance and reprocessing during one year of simulated use consisting 16,000 actuations of the device set to aspirate 3 µl. Device evaluation consisted of measuring aspirated volume at each device setting, assessment of delivered volume and the force required to actuate the 3ul default setting and 1.4 µl blow-out function.
Conclusion
The intended use, technological characteristics and non-clinical test data supports a conclusion that the EZ-Tip and EZ-Grip devices are substantially equivalent to the predicate devices.