The sterile singe-use devices are to be used in conjunction with CooperSurgical Assisted Reproduction Catheters for in-vitro fertilization procedures where passage through the cervix is impeded.

Device Description

Assisted Reproduction Catheters / Stylets are single-use sterile devices provided for use with CooperSurgical Assisted Reproduction Catheters, should passage through the cervix be impeded. The devices have an overall length of 23cm and 18cm and consist of a malleable inner stylet and a detachable rigid outer sheath, which is attached to the flexible inner stylet by a male/female Luer Lock adaptor. When the outer sheath Luer is attached to the hub of the stylet, the inner malleable stylet forms a smooth radius at the outer sheath. The outer sheath has a series of 1cm graduations at the distal end. The stainless steel stylet is encapsulated in Teflon (FEP).

AI/ML Overview

The CooperSurgical Malleable Stylet, as described in the 510(k) Premarket Notification K023382, is a single-use sterile device intended for use with CooperSurgical Assisted Reproduction Catheters during in-vitro fertilization procedures when passage through the cervix is impeded.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a Class II medical device, the acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device. This typically means showing that the new device has the same intended use, technological characteristics, and performance as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Evidence
Intended Use	The device must have the same intended use as the predicate device.	"The sterile singe-use devices are to be used in conjunction with an Edwards Catheter for in-vitro fertilization procedures where passage through the cervix is impeded." This matches the intended use of the Wallace Malleable Stylets - K990349.
Material Composition	Device materials must be compatible with biological systems and comparable to predicate.	"The subject devices are composed of the same materials..." (compared to predicate). Specific materials are listed: Teflon (FEP) for outer sheath and encapsulation, Stainless Steel (316) for inner rod (no patient contact), Polypropylene for luers, Polyethylene for tip protector (no patient contact). Biocompatibility testing equivalent to ISO 10993-1 requirements was performed.
Sterilization Method	The device must be sterilized using the same method as the predicate device.	"sterilized using the same method..." (compared to predicate). The document implies the sterilization method is the same as the predicate, but the specific method is not detailed in the provided text.
Working Dimensions	The device's working dimensions must be comparable to the predicate device.	"has the same working dimensions." (compared to predicate). Overall lengths are 23cm and 18cm. Minor differences noted: "the luers of the subject device are slightly larger (both in diameter and length) than the predicate device." The manufacturer asserts these are minor differences.
Performance Standards	The device must comply with relevant performance standards.	"complies with the same standards." (compared to predicate). Specifically mentioned: "The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements." This demonstrates acceptable mechanical fit for luer connectors.
Packaging	Packaging must ensure sterility and device integrity.	"The subject 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." This is a minor difference, and the new packaging (flexible pouch of Tyvek heat sealed to polyethylene film) is described as "designed to be peeled open," indicating suitability for maintaining sterility.
Safety and Effectiveness	Overall, the device must be as safe and effective as the predicate device.	The conclusion states: "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices." This is the ultimate objective of demonstrating substantial equivalence, supported by matching intended use, materials, sterilization, dimensions, and compliance with standards, and providing data for any differences (e.g., biocompatibility for materials, luer fitment for dimensions). The FDA's substantial equivalence determination (K023382) confirms acceptance of this conclusion.

2. Sample Size for Test Set and Data Provenance

For this 510(k) submission, the "test set" does not refer to a clinical study involving a patient cohort or a typical algorithm validation set. Instead, the "testing" involves bench testing to confirm material properties and mechanical performance.

Sample Size: Not explicitly stated as a number of stylets tested, but refers to testing conducted on device materials and luer fittings. It's implied that sufficient samples were tested to demonstrate compliance with the referenced ISO standards.
Data Provenance: The biocompatibility and luer taper testing would have been conducted in a laboratory setting, likely by the manufacturer or a contract testing organization. This is not clinical data (e.g., from a specific country or retrospective/prospective).

3. Number of Experts and Qualifications for Ground Truth for the Test Set

Not applicable. This type of regulatory submission for a simple medical device like a stylet does not involve human experts establishing ground truth for performance in the way an AI diagnostic algorithm would. The "ground truth" here is objective physical and chemical properties confirmed by standardized laboratory tests (e.g., ISO standards for biocompatibility and luer fit).

4. Adjudication Method for the Test Set

Not applicable. As described above, no expert adjudication process is relevant for bench testing of material properties and mechanical dimensions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically conducted for diagnostic imaging devices or AI algorithms where human interpretation is involved. This device is a surgical accessory, and its effectiveness is assessed through its physical and mechanical properties for its intended use, not through human reading of images or data.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

No. This device is not an algorithm or software. It is a physical medical instrument. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's compliance is based on:

Objective Technical Standards: Compliance with ISO 10993-1 (Biocompatibility) and ISO 594-1 1986 (Conical fittings with a 6% luer taper).
Material Specifications: Verifying that the device's components are made from the specified and appropriate medical-grade materials.
Dimensional Measurements: Confirming the physical dimensions (length, luer size) meet design specifications and are comparable to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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DEC 2 0 2002

FDA 510(k) Premarket Notification CooperSurgical Malleable Stylet

KO23382

510 (k) Summary

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.

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

Possible device trade names are: CooperSurgical Malleable Stylet or Edwards Malleable Stylet Common Name: Assisted Reproduction Catheters, Stylet

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

Wallace Malleable Stylets - K990349

The subject devices have the same indications for use, material composition, sterilization method, and working dimensions as the predicate device. A minor difference lies in the luers of the subject device are slightly larger (both in diameter and length) than the predicate device. The subject 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 polyethylene film. The pouch is designed to be peeled open. The pouches will be placed in a carton will contain 10 units.

The two versions are AR-ST18 (18cm length) and AR-ST23 (23cm length).

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Component	Material	Details
Stylet Outer Sheath	Teflon	Fluortek FEP-20 White (akaNeoflon NP-20)
Stylet Inner Rod	Stainless Steel	No patient contact. The 316Stainless Steel is encapsulated inTeflon (FEP).
Outer Sheath	Teflon	Fluortek FEP-20 White (akaNeoflon NP-20)
Luers	Polypropylene (pink colorantused in outer luer and blue color-ant used in stylet luer).	Montell Profax 6323 Compoundedby Chroma with PMS 240 U Pink.Montell Profax 6323 Compoundedby Chroma with PMS 300C Blue.
Tip Protector	Polyethylene	No patient contact

The subject devices are composed of the following materials:

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

The sterile singe-use devices are to be used in conjunction with an Edwards Catheter for in-vitro fertilization procedures where passage through the cervix is impeded.

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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service .

nd Drug Administration 0 Corporate Boulevard ckville MD 20850

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

Re: K023382

Trade/Device Name: CooperSurgical, Inc. Malleable Stylet Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: 85 MQF Dated: December 3, 2002 Received: December 4, 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 (OS) 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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Page 2

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.

Henry 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 Malleable Stylet

5.10(k) Number (if known): K023382

Device Name: CooperSurgical, Inc. Malleable Stylet

Indications For Use: The sterile singe-use devices are to be used in conjunction with CooperSurgical Assisted Reproduction Catheters for in-vitro fertilization procedures where passage through the cervix is impeded. : · : . :

(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

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Al and Radiological Device 510(k) Number _

Page 4 510(k) Malleable Stylet

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).