(109 days)
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Not Found
No
The summary describes a physical microtool for laboratory procedures and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No.
The device is used for micromanipulation of gametes or embryos in a laboratory setting and does not directly treat a medical condition in a patient.
No
The device description states that Microtools are used for manipulating, injecting, holding, or transferring gametes or embryos. This involves direct physical interaction for procedures rather than identifying or diagnosing a condition.
No
The device description and intended use clearly indicate a physical "microtool" used in a laboratory setting for manipulating gametes and embryos. There is no mention of software as the primary or sole component.
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use describes the device as a "microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos". These are manual manipulation procedures performed on biological samples outside the body.
- IVD Definition: IVDs are generally defined as reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Lack of Diagnostic Information: The description of the device's function does not involve analyzing the biological samples to provide diagnostic information. It's about physically manipulating them.
- Care Setting: The device is used in a "laboratory," which is consistent with IVD use, but the type of activity performed (micromanipulation) is not typically considered an IVD function.
The device appears to be a tool used in assisted reproductive technology (ART) procedures, which are laboratory-based but not primarily for in vitro diagnosis.
Therefore, based solely on the provided text, this device does not fit the typical definition of an IVD.
N/A
Intended Use / Indications for Use
Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.
Product codes
MQH
Device Description
Microtools
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 19 1999
Conception Technologies Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K991104 Microtools Dated: June 28, 1999 Received: June 30, 1999 Requiatory Class: II 21 CFR §884.6130/Procode: 85 MQH
Dear Mr. Holland:
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 (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 requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 requlations.
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 regulation 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,
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
1
Premarket Notification -- Conception Technologies - Microtools
Page 1 of 1
| 510(k) Number (if known): | K991104 |
|---|---|
| --------------------------- | --------- |
Microtools Device Name: ____________________
Indications For Use:
Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.
(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 | K991104 |
| Prescription Use | |
|---|---|
| ------------------ | -- |
OR
| Over-The-Counter | |
|---|---|
| ------------------ | -- |
Prescription Use_ 4 (Per 21 CFR 801.109)
ાર
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)