(100 days)
Not Found
Not Found
No
The summary describes a physical aspiration needle and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is used for aspiration and flushing of oocytes, which is a diagnostic or procedural step rather than a therapeutic intervention to treat a disease or condition.
No
The device is used for aspiration and flushing of oocytes, which is an interventional procedure, not a diagnostic one. It facilitates the collection of biological material rather than interpreting it to make a diagnosis.
No
The device description clearly states it is an "Ovum Pick-Up Aspiration Needle," which is a physical medical device used for aspiration and flushing. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ovum Pick-Up Aspiration Needle is a surgical instrument used to physically extract oocytes (eggs) directly from the ovarian follicles within the body. It is not used to analyze a specimen in vitro (outside the body).
The device is used in a procedure involving the body directly, not for testing a sample taken from the body.
N/A
Intended Use / Indications for Use
The Ovum Pick-Up Aspiration Needles are used for aspiration and flushing of oocytes from ovarian follicles.
Product codes
85 MQE
Device Description
The Ovum Pick-Up Aspiration Needle is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocytes from ovarian follicles.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
transvaginal ultrasound
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
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.
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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
Not Found
§ 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).
0
K983593
JAN 2 1 1999
9
510(k) Premarket Notification Ovum Pick-Up Aspiration Needle Cook OB/GYN
I. 510(k) SUMMARY
Submitted By:
Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 October 13, 1998
Device
| Trade Name: | Ovum Pick-Up Aspiration Needle |
|---|---|
| CFR Reference: | 884.6100 |
| Proposed Classification Name: | Class II 85 MQE |
Predicate Devices:
Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness.
The Ovum Pick-Up Aspiration Needle is substantially equivalent to predicate Ovum Pick-Up Aspiration Needles in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Ovum Pick-Up Aspiration Needles manufactured by Cook Australia.
Device Description:
The Ovum Pick-Up Aspiration Needle is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocytes from ovarian follicles.
Substantial Equivalence:
This device will be manufactured according to specified controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird with three wing-like shapes above a wavy line, representing the department's mission related to health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Debbie Schmitt Regulatory Affairs Manager Cook Ob/Gyn® 1100 W. Morgan Street Spencer, IN 47460
Re: K983593
Ovum Pick-up Aspiration Needles Dated: December 11, 1998 Received: December 12, 1998 Regulatory Class: II 21 CFR 884.6100/Procode: 85 MQE
Ms. Debbie 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it mav 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 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 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 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
2
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
K983593 510(k) Number (if known): Not yet assigned Ovum Pick-Up Aspiration Needles Device Name: The Ovum Pick-Up Aspiration Needles are used for aspiration and Indications for Use: flushing of oocytes from ovarian follicles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number