(144 days)
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Not Found
No
The summary describes a physical aspiration needle and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as being used for the "recovery and collection of oocytes," which is a diagnostic or procedural function, rather than directly treating a condition or disease.
No
This device is for the "recovery and collection of oocytes," which is a therapeutic or interventional procedure, not a diagnostic one. While it uses "ultrasoundguided" technology, the purpose is not to diagnose a condition but to perform a physical extraction.
No
The intended use describes a physical aspiration needle, which is a hardware device, not software.
Based on the provided information, the Mona Lisa Aspiration Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "transvaginal recovery and collection of oocytes from ovarian follicles." This describes a procedure performed on the patient's body to collect biological material.
- IVD Definition: In vitro diagnostics are tests performed outside the body on samples of biological material (like blood, urine, tissue, etc.) to provide information about a person's health.
The Mona Lisa Aspiration Needle is a surgical or procedural device used to obtain the sample, not to perform a diagnostic test on the sample itself.
N/A
Intended Use / Indications for Use
The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.
Product codes
85 MQE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasoundguided
Anatomical Site
ovarian follicles
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 9 2003
Ms. Constance W. Sturgeon President Fertility Technology Resources, Inc. 4343 Shallowford Road, Suite D-4 MARIETTA GA 30062
Re: K032208
Trade/Device Name: Mona Lisa Aspiration Needle Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted reproduction needle Regulatory Class: II Product Code: 85 MQE Dated: October 28, 2003 Received: October 29, 2003
Dear Ms. Sturgeon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
1
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K032208
Device Name: Mona Lisa Aspiration Needle
Indications For Use: The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.
Prescription Use (Part 21 CFR 801 Subpart D)
- . -
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David B. Lymm
Sit. 17-017 DIV Kadjoice cal Dev SLO (jz) Number
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