(267 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of glass pipettes, with no mention of AI or ML.
No.
The devices are intended for diagnostic purposes (to diagnose genetic disorders) or for extraction of sperm cells, not for treating a disease or condition.
Yes
The device is intended to aspirate cells (blastomere, trophectoderm, polar bodies) for the diagnosis of genetic disorders. While the device itself doesn't perform the diagnosis, it is an essential tool in obtaining the sample needed for the diagnostic process.
No
The device description clearly describes physical, borosilicate glass pipettes, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic) or a device used in conjunction with IVD procedures.
Here's why:
- Intended Use: The intended use explicitly states that the pipettes are used "to diagnose genetic disorders prior to embryo selection" and "to diagnose genetic disorders prior to embryo selection." This directly relates to obtaining samples for diagnostic testing performed in vitro (outside the body).
- Device Description: The pipettes are designed to aspirate biological material (blastomeres, trophectoderm, polar bodies, sperm cells) which are then used for diagnostic purposes.
- Predicate Devices: The predicate devices listed (K033904 and K033903) are described as "Pre-Implantation Genetic Diagnosis Pipettes" and "Intracytoplasmic Sperm Injection (ICSI), Micro-Injection Pipettes, Holding ● Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes." These are all devices commonly used in assisted reproductive technologies (ART) and pre-implantation genetic testing (PGT), which are inherently linked to in vitro diagnostic procedures.
While the device itself is a tool for sample collection, its intended use is directly tied to providing samples for in vitro diagnostic testing. Therefore, it falls under the scope of devices used in IVD procedures, and depending on the specific regulatory classification, it could be considered an IVD accessory or a device used in conjunction with IVD tests.
The fact that the document doesn't explicitly state "IVD" doesn't mean it isn't. The intended use and the context of its application strongly suggest its role in in vitro diagnostic processes.
N/A
Intended Use / Indications for Use
The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.
The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.
The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.
Product codes
MOH
Device Description
The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time 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
Prescription Use
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
- MEA Testing: The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes underwent lot release Mouse Embryo Assay testing. The acceptance criterion was that >=80% 1 cell stage embryos must develop to blastocyst within 96 hours. The predetermined acceptance criterion was met.
- LAL Testing: The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes were lot-release tested using the Limulus Amebocyte Lysate (LAL) test. The devices must demonstrate
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2016
Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47404
Re: K151018
Trade/Device Name: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted Reproduction Microtools Regulatory Class: Class II Product Code: MOH Dated: December 10, 2015 Received: December 11, 2015
Dear Naomi Funkhouser,
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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Jeffrey W. Cooper -S 2016.01.08 11:19:22 -05'00'
For
Beniamin 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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Indications for Use
510(k) Number (if known) K151018
Device Name Embryo Biopsy Pipette Polar Body Biopsy Pipette Testicular Sperm Extraction Pipette
Indications for Use (Describe)
The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.
The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.
The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.0 510(k) Summary
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, and Testicular Sperm Extraction Pipette 510(k) Summary 21 CFR §884.6130 Date Prepared: January 8, 2016
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone Number: | (812) 335-3575 x104371 |
| Fax Number: | (812) 332-0281 |
| Contact: | Naomi Funkhouser |
| Contact Address: | Cook Incorporated |
| 750 Daniels Way | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Contact Phone Number: | (812)335-3575 x104371 |
| Contact Fax Number: | 812-332-0281 |
| Device Information: | |
| Trade names: | Embryo Biopsy Pipette |
| Polar Body Biopsy Pipette | |
| Testicular Sperm Extraction Pipette | |
| Common name: | Microtools, Assisted Reproduction (Pipettes) |
| Classification Name: | Assisted Reproduction Microtools |
| Regulation: | 21 CFR §884.6130 |
| Product Code: | MQH |
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Predicate Devices:
The predicate device for the Embryo Biopsy and the Polar Body Biopsy is as follows:
-
Cook's Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) (K033904) .
The predicate device for the Sperm Extraction Pipettes is as follows: -
Cook's Intracytoplasmic Sperm Injection (ICSI), Micro-Injection Pipettes, Holding ● Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes (K033903)
Device Description:
The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time use.
Intended Use:
The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.
The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.
The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied testicular tissue.
Comparison to Predicates:
The Embryo Biopsy Pipette and the Polar Body Pipette have the same intended use as K033904 - aspiration of embryo tissues/cells for genetic diagnosis.
5
The Testicular Sperm Extraction Pipette has the same intended us as K033903 - to manipulate sperm during ART procedures.
The proposed devices have the same technological characteristics (design material, comparable dimensions) as the predicate devices.
Performance Testing:
The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes were subjected to testing as to assure validation of design and performance as listed below. In addition, the Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes undergo MEA and LAL testing for each lot manufactured.
-
- MEA Testing The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes underwent lot release Mouse Embryo Assay testing. The acceptance criterion was that ≥80% 1 cell stage embryos must develop to blastocyst within 96 hours. The predetermined acceptance criterion was met.
-
- LAL Testing The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes were lot-release tested using the Limulus Amebocyte Lysate (LAL) test. The devices must demonstrate