The subject devices are single-use, sterile, disposable, flexible catheters with rounded smooth distal ends, provided for the introduction of embryos into the uterine cavity during in vitro fertilization or Embryo Transfer procedures. The subject devices are available in working lengths of 18cm including Luer Lock adaptors that are affixed at their proximal ends. The inner catheter is a clear tube with a 1.8mm outer and a 0.8mm inner diameter. The inner catheter is surrounded by an outer sheath with a 2.3mm outer diameter. This inner catheter has a series of graduated markings that are placed 1cm apart at the proximal end to provide reference to the degree of inner catheter insertion to the uterus during embryo placement. The distal of the outer sheath possesses a gradual taper and is shorter than the inner catheter. Jeaving the distal 5cm of the inner catheter exposed. The proximal circumference of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock adaptor. Five black graduation markings are located on the distal portion of the outer sheath at 1cm increments to indicate the degree of advancement into the cervix.

AI/ML Overview

The provided 510(k) summary for the CooperSurgical Embryo Transfer Catheter (K023379) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/software performance studies.

This 510(k) is for a physical medical device (catheter), and the "performance data" section focuses on physical and material properties rather than diagnostic performance or efficacy for medical image analysis.

Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance for an AI/software device, nor can I answer the questions related to sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

However, based on the information provided, I can infer the types of "acceptance criteria" and "studies" relevant to this specific device:

Types of "Acceptance Criteria" and "Studies" Applicable to this Device (Based on the 510(k) Summary):

The acceptance criteria for this physical medical device are related to its material properties, dimensions, and manufacturing processes to ensure safety and equivalence to a predicate device. The "studies" are tests conducted to demonstrate these properties.

Here's how aspects of the request align with the provided document for this physical device:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied from the document):
  - Biocompatibility (equivalent to ISO 10993-1)
  - Conical fittings comply with ISO 594-1 1986 (6% luer taper)
  - Sterility (SAL 10^-6) via validated Ethylene Oxide cycle
  - Mechanical integrity (e.g., sufficient stiffness for AR-ET23F, flexible with rounded smooth distal ends)
  - Dimensional specifications (working lengths, inner/outer diameters, luer dimensions)
  - Material composition identical to stated components
  - Packaging integrity
- Reported Device Performance (as stated):
  - "The subject device has been subject to biocompatibility testing (for the materials 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."
  - "The subject devices will be sterilized using validated Ethylene Oxide cycle affording an SAL 10^-6 to sterility level."
  - The device characteristics (materials, dimensions) are listed as designed.
Sample size used for the test set and the data provenance: This is not applicable. The "tests" mentioned are for physical device properties (biocompatibility, luer taper, sterility), not for evaluating diagnostic or algorithmic performance with a "test set" of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is based on established engineering standards and material science, not clinical expert consensus on a test set.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not applicable to a physical embryo transfer catheter. MRMC studies are for assessing diagnostic performance of imaging systems or AI algorithms.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. This is a physical device, not an algorithm.
The type of ground truth used: For this device, the "ground truth" for compliance would be established through:
- Laboratory testing against ISO standards (e.g., for biocompatibility, luer taper).
- Chemical/material analysis to verify stated composition.
- Physical measurements to verify dimensions.
- Microbiological testing for sterility.
The sample size for the training set: Not applicable. This is a manufactured medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) for the CooperSurgical Embryo Transfer Catheter (K023379) demonstrates substantial equivalence through adherence to existing standards for physical devices and material compatibility, not through clinical performance studies against a 'ground truth' as one would expect for an AI/software device.

Summary

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510 (k) Summarv

K023379

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

October 7, 2002

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

Joseph M. Azary C/o CooperSurgical, Inc. P.O. Box 2156 Huntington, 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. CooperSurgical, Inc. is an FDA-registered medical device under establishment# 1216677.

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

Trade Name: CooperSurgical Embryo Transfer Catheter or CooperSurgical Embryo Transfer Catheter.

Common Name: Embryo Transfer Catheter

Classification: Class II, 21 CFR 884.6110, MQF

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

Wallace Catheters - K990350

The subject devices have the same indications for use, material composition, sterilization method, and working dimensions as the predicate. A minor difference lies in the fact that the luers of the subject device are slightly larger (both in diameter and length) than the predicate device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film.

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 polyethviene film. The pouch is designed to be peeled open. The pouch will be placed in a white SBS carton will

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FDA 510(k) Premarket Notification CooperSurgical Embryo Transfer Catheter

contain 10 mits. The subject devices will be sterilized using validated Ethylene Oxide cycle affording an SAL 10to sterility level.

The three versions to be offered are: AR-ET18 (18cm), AR-ET23 (23cm), and AR-ET23F (23cm Firm). The AR-ET23F contains a slightly stiffer 16 Ga. 23cm catheter.

The subject devices are composed of the following materials:

Component	Material	Details
Inner Catheter	Polyurethane	Pellethane 2363-90A R0120 Poly-urethane
Outer Sheath	Teflon	Fluortek FEP-20 White (akaNeoflon NP-20) with 8-10% Bar-ium Sulfate.
Luers	Polypropylene (with Pink andGreen Colorants).	Montellprofax 6323 Compoundedby Chroma with PMS 240 U Pink.Montellprofax 6323 Compoundedby Chroma with PMS 36K Green.
Tip Protector	Polyethylene	No patient contact

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

The sterile single-use device is to be used for the introduction of embryo(s) the uterine cavity during assisted reproductive procedures.

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 has the same working dimensions. The minor differences are with the packaging and the outer diameter and length of the Luer.

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

The subject device has been subject to biocompatibility testing (for the materials 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 symbol that resembles an abstract human figure with three flowing lines representing the department's mission to protect and promote the health and well-being of all Americans.

Public Health Service

d and Drug Administration Corporate Boulevard ckville MD 20850

CooperSurgical, Inc. % Joseph M. Azary Azary Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484 Re: K023379 Trade/Device Name: CooperSurgical Embryo Transfer Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheter Regulatory Class: II Product Code: 85 MQF Dated: October 7, 2002

Received: October 8, 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 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 this 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" (21 CFR Part 807.97). 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. Snogdon

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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FDA 510(k) Premarket Notification CooperSurgical Embryo Transfer Catheter

510(k) Number (if known):

K023379

Device Name: CooperSurgical Embryo Transfer Catheters

Indications For Use: The sterile single-use device is to be used for the introduction of embryo(s) into uterine cavity during assisted reproductive procedures. . . . . .

(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 __

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023379

Page 4

Regulation Number and Section

§ 884.6110 Assisted reproduction catheters.

(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).