(81 days)
Not Found
No
The device description and intended use clearly define the device as a physical catheter for embryo transfer and trial transfer. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is used for the introduction of embryos into the uterine cavity, which is a procedural step in in-vitro fertilization, and for assessing passage through the cervix. These functions are not defined as therapeutic as they do not directly treat a disease or medical condition.
No
The "Trial Transfer Catheters" are described as being used "for determining whether the cervix is passable for a Wallace embryo replacement catheter" and "used to assess the passage through the cervix prior to embryo transfer," which are diagnostic activities. However, the question asks "Is this device a diagnostic device?" implying the overall submission. The submission also includes "Embryo Replacement Catheters" whose intended use is "introduction of embryos into the uterine cavity following in vitro fertilisation," which is a therapeutic/interventional procedure, not diagnostic. Since the submission encompasses both diagnostic and non-diagnostic components, the device as a whole is not solely a diagnostic device.
No
The device description clearly details physical components (catheters, cannulas, sheaths) and their dimensions, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
- Device Function: The descriptions clearly state that these catheters are used for the introduction of embryos into the uterine cavity or for assessing passage through the cervix. They are instruments used within the body for a procedural purpose, not for analyzing biological samples outside the body.
- Intended Use: The intended uses describe a procedure (embryo transfer) and a preparatory step for that procedure (trial transfer), not a diagnostic test performed on a sample.
Therefore, these devices fall under the category of medical devices used for a therapeutic or procedural purpose, not for in vitro diagnosis.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
85 MQF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
uterine cavity (for embryo replacement), cervix (for trial transfer)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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.
3
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.
4
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
5
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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .