The Aspiration/Ovum Pick-Up Aspiration Needles with AQ Coating are used for general irrigation/aspiration and flushing of oocytes from ovarian follicles.

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.

AI/ML Overview

The provided text is a 510(k) summary for Ovum Pick-Up Aspiration Needles with AQ Coating and Aspiration Needles with AQ Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for novel devices.

Therefore, the document does not contain the information requested regarding:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
Information on standalone algorithm performance.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Explanation Based on the Provided Document:

The acceptance criteria for a 510(k) submission like this are primarily about demonstrating substantial equivalence to existing, legally marketed predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate.

The study proving the device meets these acceptance criteria, as described in the 510(k) summary (Section {0}), is a comparison to predicate devices.

Key Information from the Document Regarding "Acceptance Criteria" (Substantial Equivalence) and "Study" (Comparison to Predicate):

Predicate Devices: The Ovum Pick-Up Aspiration Needles with AQ Coating and the Aspiration Needles with AQ Coating are deemed substantially equivalent to predicate devices including:
- Cook OB/GYN Ovum Pick-Up Needles
- Aspiration Needles (Cook OB/GYN)
- Hydrophilic Dilators (Cook OB/GYN, Cook Urological)
- Hydrophilic Catheters (Cook OB/GYN, Cook Urological)
Basis for Substantial Equivalence (the "Study"): "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." (Section {0})
Device Description:
- Ovum Pick-Up Aspiration Needles with AQ coating: "used for transvaginal ultrasound or laparoscopic aspiration/flushing of oocves from ovarian follicles."
- Aspiration Needles with AQ coating: "used for general aspiration and irrigation."
Substantial Equivalence Statement: "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." (Section {0})

This 510(k) submission is a regulatory filing, not a scientific study designed to establish quantitative performance metrics against specific acceptance criteria for a novel technology. It relies on the pre-existing safety and effectiveness of predicate devices.

Summary

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MAR - 1 2000

K99 4417

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	85MQE79GAA
Trade Name:	Ovum Pick-Up Aspiration Needles with AQ CoatingAspiration Needles with AQ Coating
CFR Reference:	884.6100878.4800
Proposed Classification Name:	Ovum Pick-Up Aspiration Needles with AQ CoatingAspiration 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:

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.

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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)

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

K994417 510(k) Number (if known):

Device Name:	Aspiration Needles/Ovum Pick-Up Aspiration Needleswith AQ Coating
Indications for Use:	The Aspiration/Ovum Pick-Up Aspiration Needleswith AQ Coating are used for general irrigation/aspirationand 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)

Over-The-Counter Use_

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number_

Regulation Number and Section

§ 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).