(63 days)
Not Found
Not Found
No
The summary describes a physical aspiration needle with a coating and its intended use for aspiration and flushing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is used for aspiration/flushing, which is a diagnostic/interventional procedure, not a therapeutic treatment.
No
The device is used for aspiration/flushing of oocytes, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is a physical needle used for aspiration and flushing, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used for the aspiration and flushing of oocytes from ovarian follicles and for general irrigation/aspiration and flushing. This is a procedure performed on the patient's body, not on a specimen taken from the patient's body for analysis.
- The device is used in conjunction with imaging modalities (transvaginal ultrasound or laparoscopic) to guide a procedure. This further indicates it's a surgical or procedural device, not a diagnostic test performed on a sample.
The device is a surgical/procedural instrument used for retrieving biological material directly from the body, not for analyzing a sample in a laboratory setting.
N/A
Intended Use / Indications for Use
The Aspiration/Ovum Pick-Up Aspiration Needles with AQ Coating are used for general irrigation/aspiration and flushing of oocytes from ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
85MQE, 79GAA
Device Description
The Ovum Pick-Up Aspiration Needles with AQ coating is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocves from ovarian follicles. The Aspiration Needles with AQ coating are used for general aspiration and irrigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
transvaginal ultrasound
Anatomical Site
ovarian follicles
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.
The Ovum Pick-Up Aspiration Needles with AQ Coating and the Aspiraiton Needles with AQ Coating are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Cook OB/GYN Ovum Pick-Up Needles and the Aspiration Needles. The predicate AQ devices include the Hydrophilic Dilators, and Hydrophilic catheters manufactured and marketed by Cook OB/GYN (Cook Urological).
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
§ 884.6100 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
MAR - 1 2000
K99 4417
9
510(k) Premarket Notification Ovum Pick-Up Aspiration Needles with AQ Cook OB/GYN
L 510(k) SUMMARY
Submitted By:
Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 October 13, 1998
| Device | 85MQE
79GAA |
|-------------------------------|---------------------------------------------------------------------------------------|
| Trade Name: | Ovum Pick-Up Aspiration Needles with AQ Coating
Aspiration Needles with AQ Coating |
| CFR Reference: | 884.6100
878.4800 |
| Proposed Classification Name: | Ovum Pick-Up Aspiration Needles with AQ Coating
Aspiration Needles with AQ Coating |
Predicate Devices:
The Ovum Pick-Up Aspiration Needles with AQ Coating and the Aspiraiton Needles with AQ Coating are substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Cook OB/GYN Ovum Pick-Up Needles and the Aspiration Needles. The predicate AQ devices include the Hydrophilic Dilators, and Hydrophilic catheters manufactured and marketed by Cook OB/GYN (Cook Urological).
Device Description:
The Ovum Pick-Up Aspiration Needles with AQ coating is used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocves from ovarian follicles. The Aspiration Needles with AQ coating are used for general aspiration and irrigation.
Substantial Equivalence:
These devices 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, these devices meet the requirements for section 510(k) substantial equivalence.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping lines forming the face. The seal is black and white.
MAR - 1 ZUUL
Ms. Debbie Schmitt Requlatory Affairs Manager COOK® Urological 1100 W. Morgan Street Spencer. IN 47460
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K994417
Ovum Pick-Up Aspiration Needles with AQ (Hydrophilic) Coating and Aspiration Needles with AQ (Hydrophilic) Coating Dated: December 23, 1999 Received: December 29, 1999 Regulatory Class: Il 21 CFR §884.6100/Procode: 85 MQE
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 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) 594-4591. 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 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,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
2
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
K994417 510(k) Number (if known):
| Device Name: | Aspiration Needles/Ovum Pick-Up Aspiration Needles
with AQ Coating |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Aspiration/Ovum Pick-Up Aspiration Needles
with AQ Coating are used for general irrigation/aspiration
and 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_
Jt
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number_