Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.

Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter

Device Description

Embryo Replacement Catheters: The Embryo Replacement Catheters (for use in ultrasound-guided transfers) are single use devices for the introduction of embryos into the uterine cavity following in-vitro fertilisation. The devices have overall lengths; 18cm (CE 118A) and 23cm (CE 123A) and consist of a soft, flexible inner cannula, with end opening, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a lumen that is uniform throughout its length, with a series of 1cm graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.

Trial Transfer Catheters: The Trial Transfer Catheters (for use in ultrasound-guided transfers) are single use devices used to assess the passage through the cervix prior to embryo transfer. The devices have overall lengths; 18cm (CE 418A) and 23cm(CE 423A) and consist of a flexible inner cannula, with blind end, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a series of graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies proving efficacy and safety with specific acceptance criteria as you might find for a novel device.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance derived from a study proving the device meets those criteria. Specifically, it lacks:

Explicit Acceptance Criteria: The document does not define specific performance metrics (ee.g., sensitivity, specificity, accuracy, precision, etc.) that the device must meet, nor does it quantify acceptable thresholds for these metrics.
A "Study" in the traditional sense: There isn't a prospective or retrospective clinical trial described with a defined protocol, recruitment, data collection, and statistical analysis to assess the device's performance against pre-defined criteria.
Reported Device Performance: Since there's no study, there are no reported numerical performance results for the device.

Instead, the submission relies on the concept of substantial equivalence. The performance section states: "Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects." This implies that the device's performance characteristics are considered to be similar enough to the predicate devices that no new robust performance studies are deemed necessary by the submitter or the FDA (as indicated by the clearance letter).

Here's a breakdown of why the requested information isn't available in the provided text, and what information is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for this 510(k))	Reported Device Performance (Not Quantified for this 510(k))
No explicit numerical performance criteria are defined in this 510(k) submission. The basis for clearance is "substantial equivalence" to predicate devices.	No quantitative performance metrics are reported from a dedicated study in this 510(k) submission. The submission claims "comparison of the performance... with the predicate confirms substantial equivalence in all aspects."

Explanation: In a 510(k) for a substantially equivalent device, the "acceptance criteria" are implicitly that the device performs as well as or similarly to the predicate device, especially for its intended use and any new technological characteristics. Here, the key technological difference is enhanced ultrasound visibility, which is stated to be substantially equivalent to another predicate (Cook Echotip®). The "study" proving this is a comparison to the predicate devices rather than a de novo clinical trial with specific performance endpoints.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: The document does not describe a clinical "test set" or a study involving patient data to assess performance. The comparison for substantial equivalence appears to be based on design, material, and manufacturing similarities, and the inherent properties of the enhanced ultrasound visibility material compared to a similar predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided: There is no clinical "test set" and therefore no ground truth established by experts described in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No: This is a submission for a physical medical catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study with AI assistance is not relevant and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No: This is a physical medical catheter, not an algorithm, so a standalone performance study in this context is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Not Provided: No ground truth in the context of clinical performance assessment is described, as the submission focuses on substantial equivalence based on material, design, and intended use comparison to predicate devices. The "ground truth" for clearance in this context is the FDA's determination that the new device is as safe and effective as the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable / Not Provided: As there is no AI component or machine learning model, there is no "training set" in the context of this device.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: No training set is described.

Summary of what the document does provide regarding the "study":

The "study" in this 510(k) context is a demonstration of substantial equivalence to predicate devices. The key comparison for performance relates to the enhanced ultrasound visibility. The submission states:

"The proposed devices are made from the same materials as Predicate 1 & 2. with the exception that the material is modified to enhance the visibility of the catheter under ultrasound. In this respect, the inner catheter is substantially equivalent to Predicate 3 [Cook Echotip® Soft-Pass Embryo Transfer Catheter already marketed in the USA under K983594]."
"Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects."

This indicates that the "proof" the device meets implied performance criteria (i.e., being safe and effective for its intended use, particularly with enhanced ultrasound visibility) is based on:

Material and design similarity: The proposed device's physical characteristics (tip protector, outer sheath, print markings, hubs) are identical or substantially equivalent in material composition and profile to existing predicate devices (Wallace Embryo Transfer Catheter, K990350; Wallace Trial Transfer Catheter, K990348).
Comparison of enhanced feature to an already cleared predicate: The ultrasound visibility feature is deemed substantially equivalent to another predicate that already possesses such a feature (Cook Echotip® Soft-Pass Embryo Transfer Catheter, K983594).

No new clinical trials with specific performance endpoints were required or conducted as part of this 510(k) submission.

Summary

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DEC 1 9 2003

Wallace (Sure View IM) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

K-23084

SECTION 5.0 : 510K SUMMARY

27 August 2003 DATE SUBMITTED:

SUBMITTER: Portex Ltd Hythe Kent England, CT21 6JL

CONTACT PERSON: Mr Steve Ogilvie, Regulatory and Scientific Affairs Director, Portex Ltd, Military Road, Hythe, Kent, England. CT21 6DB Phone 00 44 (0)1303 208011 Fax 00 44 (0)1303 262798

Wallace (Sure View TM )Embryo Replacement Catheter DEVICE NAME: & Trial Transfer Catheter.

COMMON NAME AND CLASSIFICATION:

Ultra sound visible embryo transfer catheter Class II MQF, 21 CFR 884.6110

PREDICATE DEVICES:

Predicate 1: Wallace Embryo Transfer Catheter range 18-23cm already marketed in the USA . under K990350
Predicate 2: Wallace Trial Transfer Catheter range 18-23cm already marketed in the USA under . K990348
Predicate 3: Cook Echotip® Soft-Pass Embryo Transfer Catheter already marketed in the USA t under K983594

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Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

DEVICE DESCRIPTION:

Embryo Replacement Catheters

The Embryo Replacement Catheters (for use in ultrasound-guided transfers) are single use devices for the introduction of embryos into the uterine cavity following in-vitro fertilisation. The devices have overall lengths; 18cm (CE 118A) and 23cm (CE 123A) and consist of a soft, flexible inner cannula, with end opening, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a lumen that is uniform throughout its length, with a series of 1cm graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the

Trial Transfer Catheters.

distal end.

The Trial Transfer Catheters (for use in ultrasound-guided transfers) are single use devices used to assess the passage through the cervix prior to embryo transfer.

The devices have overall lengths; 18cm (CE 418A) and 23cm(CE 423A) and consist of a flexible inner cannula, with blind end, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a series of graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.

TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:

The proposed devices are substantially equivalent to Predicate devices 1 & 2 -Wallace Embryo Transfer Catheter (K990350) & Wallace Trial Transfer Catheter (K990348) in all the following aspects:

Tip protector. The tip protector for the proposed devices 1 & 2 is identical in material . composition to that of Predicate 1 & 2.
Outer sheath. The outer sheath for the proposed devices 1 & 2 is identical in material . composition and profile to that of Predicate 1 & 2.
. The print markings. The print ink for the proposed devices 1 & 2 is identical in composition to the ink used for Predicate 1 & 2. The print layout for the proposed device displays identical information as the layout on Predicate 1 & 2.
Outer and inner hub. The material composition for the outer and inner hub is identical . for both the proposed devices 1 & 2 and Predicate 1 & 2.
Inner catheter. The proposed devices are made from the same materials as Predicate 1 ● & 2. with the exception that the material is modified to enhance the visibility of the catheter under ultrasound. In this respect, the inner catheter is substantially equivalent to Predicate 3.

Image /page/1/Picture/15 description: The image shows a hand-drawn symbol of a five-pointed star inside of a circle. The star is not perfectly symmetrical, and the circle is slightly irregular. The drawing appears to be done with a thick marker or pen, giving it a bold and simple look.

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Wallace (Sure View TM ) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

SECTION 5.0 : 510K SUMMARY

PERFORMANCE / CLINICAL DATA:

Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects.

CONCLUSION:

Comparison of the proposed device to the predicate devices supports the conclusion that the proposed Comparison of the equivalent to existing legally marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Mr. Barry Smith Regulatory Affairs Manager Portex, Ltd. Boundary Road, Hythe Kent CT21 6JL UNITED KINGDOM

Re: K033084

Trade/Device Name: Wallace (Sure View™) Embryo Replacement Catheter and Trial Transfer Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheter Regulatory Class: II Product Code: 85 MQF Dated: August 27, 2003 Received: September 30, 2003

Dear Mr. Smith:

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 such 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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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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Wallacc (Sure View TM ) Embryo Replacement Catheters & Trial Transfer Catheters. 510(K) Notification

SECTION 4.0: STATEMENT OF INDICATION FOR USE

510(K) Number (if known): K033084

Page 1 of 1

DEVICE NAME:

Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters.

INDICATIONS FOR USE:

Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.

Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David M. Sezeram

-productive, Abdor 510(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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).