(330 days)
Not Found
Not Found
No
The summary describes a physical needle set for oocyte collection and flushing, with no mention of software, algorithms, or AI/ML terms.
No
The device is described as an "oocyte collection needle set" used for "aspiration and flushing of gametes/oocytes." This function is for collection, not for treating a disease or condition, which is characteristic of a therapeutic device.
No
The device is described as an "assisted reproduction needle" intended for "aspiration and flushing of gametes/oocytes." This is an interventional or therapeutic procedure, not a diagnostic one. It is used to collect samples, not to determine the nature or cause of a disease or condition.
No
The intended use describes a physical needle set, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "aspiration and flushing of gametes/oocytes from the body." This describes a procedure performed on the body to collect biological material, not a test performed on biological material outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances (analytes)
- Providing diagnostic information
- Using reagents or test kits
The device is a needle set used for a medical procedure (assisted reproduction), not a diagnostic test.
N/A
Intended Use / Indications for Use
The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.
Product codes
85 MQE
Device Description
Casmed UK Single Lumen Oocyte Collection Needle Set
Casmed UK Double Lumen Oocyte Collection Needle Set
Casmed UK Single Lumen Needle
Casmed UK Double Lumen Needle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gametes/oocytes from the body
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)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2000
Ms. Debbie Castle CASMED UK Castle House 39 Nork Way Banstead Surrey SM7 1PB ENGLAND
Re: K991271
Oocvte Aspiration Needles Dated: February 8, 2000 Received: February 14, 2000 Requlatory Class: II 21 CFR 884.6100/Procode: 85 MQE
Dear Ms. Castle:
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 26, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 equivation 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 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 predication 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) 594-4591. Additionally, for question 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 807.97). Other general information on your resonsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
Indications for Use Form
Page____of___
510(k) Number (if known): __
Device Name:
Indications For Use:
Casmed UK Single Lumen Oocyte Collection Needle Set Casmed UK Double Lumen Oocyte Collection Needle Set Casmed UK Single Lumen Needle Casmed UK Double Lumen Needle
The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1 (
Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991271 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | ------------------------------------------------- | ---- | ---------------------- |
(Per 21 CFR 801/109)(Optional Format 1-2-96)