(115 days)
Not Found
Not Found
No
The device description and performance studies focus solely on the physical properties and function of glass pipettes for manual manipulation of oocytes and embryos. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device facilitates in vitro fertilization procedures by manipulating oocytes; it does not directly treat a disease or condition in a patient.
No
The device description indicates that the pipettes are used for various manipulations of oocytes and embryos (e.g., sperm injection, holding, denuding, assisted hatching), which are interventional procedures, not diagnostic ones. The mentions of "Mouse Embryo Toxicity testing" are for material safety, not diagnostic performance.
No
The device description explicitly states the devices are manufactured entirely from borosilicate glass, indicating they are physical instruments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices (ICSI Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching/Zona Drilling Pipettes) are tools used for manipulating oocytes and embryos outside the human body. They are used in assisted reproductive technology procedures (like IVF and ICSI) to physically handle and modify the cells.
- Lack of Diagnostic Testing: The description focuses on the physical manipulation of biological material (oocytes, sperm, embryos) and does not involve any chemical, biological, or immunological tests performed on samples to diagnose or monitor a condition.
- Performance Study: The only performance study mentioned is Mouse Embryo Toxicity testing, which assesses the safety of the material in contact with embryos, not the diagnostic capability of the device.
Therefore, these pipettes are considered medical devices used in a laboratory setting for assisted reproductive procedures, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.
Product codes (comma separated list FDA assigned to the subject device)
85MQH
Device Description
The Intractoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
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): 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.
Not Found
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
10(k) Premarket Notification tracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes Cook OB/GYN
11
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS L
Submitted By:
FEB
Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 October 13, 1998
Device:
Trade Name:
Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes
| Proposed Classification Name: | Class II Assisted Reproduction Microtools | |
|---|---|---|
| 85MQH | ||
| CFR Reference: | 884.6130 |
Predicate Devices:
Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used other devices as well as Cook Australia devices as our predicate to illustrate safety and effectiveness.
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are substantially equivalent to other pipettes in terms of indications for use, design, construction and materials equivalence.
Specifically, these devices are similar to the Intracytoplasmic Micropipet and Holding Micropipet manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way (No. 2), Charlottesville, VA 22901-7928, the Laboratory Micropipette Art. No. 33311 and Laboratory Micropipette Art. No. 22218 manufactured by SWEMED LAB International AB, Box 4014 S-421 04 V. Frolunda, Sweden and the (ICSI) pipettes, holding
pipettes, denuding pipettes and assisted hatching/zona drilling pipettes manufactured and distributed in Europe by Cook Australia, 12 Electronics Street, Brisbane Industrial Park, Eight Miles Plains, Queensland, 4113, Australia.
Device Description:
The Intractoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.
1
Image /page/1/Picture/2 description: The image shows a logo or seal with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN". Inside the circle is a stylized graphic of three overlapping figures or shapes, possibly representing people or abstract forms. The overall design is simple and monochromatic.
5 1999 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debbie Schmitt Regulatory Affairs Manager Cook Ob/Gyn® 1100 West Morgan Spencer, IN 47460
Re: K983596
Intracytoplasmic Sperm Injection Micro-Injection Pipettes, Holding Pipettes and Assisted Hatching/Zona Drilling Pipettes Dated: December 23, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 884.6130/Procode: 85 MQH
Dear Ms. Schmitt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Cont. Daniel C. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT JOE 35 S
510(k) Number (if known): Not yet assigned
Device Name:
Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes Holding Pipettes Denuding Pipettes Assisted Hatching/Zona Drilling Pipettes
Indications for Use:
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983596/S002 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |