The oocyte recovery needles are single use sterile devices provided for ultrasound guided transvaginal collection and recovery of oocytes from ovarian follicles for use during assisted conception procedures. The set consist of a single lumen, stainless steel needle attached to tubine. The needle is 33 cm in length and available in 16 Ga. or 17 Ga. Each device has 2 cm of echogenic markings at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. The tubing is attached to the proximal end of the needle and protrudes a total distance of 90 cm until it terminates in a silicone bung.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for CooperSurgical Oocyte Recovery Needles. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and performance metrics against specific acceptance criteria like an AI device would.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment typically associated with the evaluation of AI/ML-driven devices.

Instead, the submission focuses on comparing the new device to a predicate device based on its intended use, technological characteristics, and materials.

Here's a breakdown of why the requested information is absent and what the document does provide:

Table of acceptance criteria and reported device performance: This is not present. The submission's "Performance Data" section states that the device has undergone biocompatibility testing (equivalent to ISO 10993-1) and complies with ISO 594-1 1986 (luer taper requirements). These are standards for material safety and physical characteristics, not performance metrics like accuracy, sensitivity, or specificity.
Sample size used for the test set and data provenance: Not applicable. There was no "test set" in the context of AI/ML evaluation for this device. The biocompatibility and luer taper tests would have their own sample sizes for material/component testing, but these are not detailed in the summary.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. No "ground truth" was established by experts for performance evaluation in the AI/ML sense.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not done as it's not relevant for this type of medical device submission. The device is a needle, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable as there is no AI/ML component.
How the ground truth for the training set was established: Not applicable.

What the document does state regarding the "device meeting acceptance criteria" (in the context of a 510(k) submission):

The "acceptance criteria" in this context are interpreted as demonstrating substantial equivalence to a predicate device and adherence to relevant safety and quality standards rather than clinical performance metrics.

Acceptance Criteria & Device "Performance" (as per the 510(k) document):

Acceptance Criteria (Demonstrated Equivalence/Compliance)	Reported Device Performance (as stated in submission)
Intended Use Equivalence	The subject device has the same indications for use as the predicate device: "ultrasound guided transvaginal recovery and collection of oocytes from ovarian follicles."
Material Composition Equivalence	The subject device states it is "composed of the same materials" as the predicate for most components. (Minor difference noted: needle hub is ABS vs. methyl pentene in predicate).
Sterilization Method Equivalence	"sterilized using the same method" (Ethylene Oxide).
Working Dimensions Equivalence	"similar dimensionally" to the predicate. (Minor difference noted: luer is slightly larger in diameter and length).
Biocompatibility (for patient-contacting materials)	Subjected to biocompatibility testing "equivalent to ISO 10993-1 Biocompatibility requirements."
Luer Taper Requirements (for fittings)	Complies with "ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements."
Technological Characteristics Equivalence (overall safety and effectiveness)	CooperSurgical Inc. believes the subject device is substantially equivalent to the predicate device, citing shared materials, sterilization, standards, and indications for use.
Conclusion of Safety and Effectiveness (relative to predicate)	"We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices."

Summary of missing information:

All points 1-9 regarding specific performance metrics, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this 510(k) submission for a non-AI medical device. The submission focuses on demonstrating substantial equivalence to an already marketed predicate device, rather than proving de novo safety and efficacy through a performance study against specific clinical endpoints.

Summary

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FDA 510(k) Premarket Notification CooperSurgical Oocyte Recovery Needles

510 (k) Summarv

JAN 2 2 2003

Date Prepared [21 CFR 807.92(a)(1)]

November 22, 2002

Submitter's Information [21 CFR 807.92(a)(1)}

Joseph M. Azary C/o CooperSurgical Inc. 543 Long Hill Avenue Shelton, CT. 06484

Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor CooperSurgical Inc., 95 Corporate Drive, Trumbull, CT 06611.

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade names are: CooperSurgical Oocyte Recovery Needles Common Name: Assisted Reproduction Needles

Predicate Device [21 CFR 807.92(a)(3)]

SIMS Portex, Wallace Oocyte Retrieval Set - K012068

The subject devices have the same indications for use, material composition, sterilization method, and working dimensions. The main difference is the luer of the subject device is slightly larger (both in diameter and length) than the predicate device and the subject device has a needle hub composed of ABS instead of methyl pentene.

Description of the Device [21 CFR 807.92(a)(4)}

The subject devices will be packaged in a flexible pouch composed of Tyvek heat sealed to polyethylene film. The pouch is designed to be peeled open. The pouch will be placed in a white carton box. Each carton will contain 10 units. The subject devices will be sterilized using Ethylene Oxide using SAL 10°.

The two versions to be offered are: 16 Ga. (AR-N1695) and 17 Ga. (AR-N1795).

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Component	Material	Details
Needle Hub	ABS (Acrylonitrile ButadieneStyrene)	Bayer Lustran 266 ABS
Needle	Stainless Steel	304 Stainless Steel
Needle Guard	Polyethylene	No patient contact
Stopper	Silicone	Dow Corning Material Q7-4840
Luer	Polypropylene	Montellprofax 6323 Compoundedby Chroma with PMS 240 U Pink.
Large OD Tubing	Polyurethane	Pellethane 2363-90A R0120 Poly-urethane
Small OD Tubing	Polyurethane	Pellethane 2363-90A R0120 Poly-urethane
Small Sleeve	Silicone	Dow Corning Material Q7-4840
Tip Protector	Polyethylene	No patient contact

The subject devices are composed of the following materials:

Intended Use [21 CFR 807.92(a)(5)}

The device is for ultrasound guided transvaginal recovery and collection of occytes from ovarian follicles.

Technological Characteristics [21 CFR 807.92(a)(6)]

CooperSurgical Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and is similar dimensionally. There are minor differences with the packaging, outer diameter and length of the Luer, and the material of the needle hub.

Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subject to biocompatibility testing (for the materials that contact that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.

Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2003

CooperSurgical, Inc. % Mr. Joseph M. Azary Manager AZARY Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484

Re: K023930

Trade/Device Name: CooperSurgical Oocyte Recovery Needles Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted reproduction needles Regulatory Class: II Product Code: 85 MQE Dated: November 22, 2002 Received: November 25, 2002

Dear Mr. Azary:

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 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.

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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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5 10(k) Number (if known): _ KO23930

Device Name: CooperSurgical Inc. Oocyte Recovery Needles

Indications For Use: The device is for ultrasound guided transvaginal recovery and collection 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)

David A. Lynn

(Division Sian-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Page 4 510(k) CooperSurgical Oocyte Recovery Needle

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).