(32 days)
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No
The device description and performance studies focus on the physical components and biological safety of a needle and tubing system for oocyte retrieval, with no mention of AI or ML.
Yes
A therapeutic device is one that performs a therapeutic action, which includes the removal of something from the body. This device is intended for the retrieval and collection of oocytes, which is a therapeutic action.
No
The device is used for the retrieval and collection of oocytes, which is a procedural function, not a diagnostic one. It facilitates a medical procedure rather than providing information to diagnose a condition.
No
The device description clearly outlines physical components like a needle, tubing, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is the retrieval and collection of oocytes from ovarian follicles. This is a procedure performed on the patient's body (transvaginal) to obtain a biological sample.
- Device Description: The device is a needle and tubing set designed for physically extracting the oocytes. It's a tool for a medical procedure.
- Lack of Diagnostic Function: The device itself does not perform any analysis or testing of the collected oocytes or any other biological sample to provide diagnostic information about a patient's condition. IVDs are typically used to examine samples outside the body to diagnose, monitor, or screen for diseases or conditions.
While the collected oocytes might be used in subsequent in vitro procedures (like IVF), the Wallace Oocyte Retrieval Set's function is solely the collection of the sample, not the diagnostic analysis of it.
N/A
Intended Use / Indications for Use
The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles.
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
85 MQE
Device Description
Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
ovarian follicles
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biological safety assessment of the Wallace Oocyte Retrieval Set has been performed in accordance with the International Standard ISO 10993, Part 1:1994, "Biological Evaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993 the selection of tests, taking into consideration the particular application of the product e.g. collection of human oocytes, embryo toxicity and bacterial endotoxin tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 884.6100 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).
0
AUG - 3 2001
510(k) SUMMARY
The Summary of Safety and Effectiveness on the Wallace Oocyte Retrieval Set reflects data available and The Summary of Satety and Extectiveless on the valued be excrised in interpreting the represented at the time the submission was prepared, but cautions or recommended tons set forth.
| Applicant | Claire Mullins
SIMS Registration Manager
SIMS Portex Ltd
Hythe
Kent CT21 6JL
UK |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 44 1303 260551 |
| Facsimile | 44 1303 266761 |
| Date | 19 July 2001 |
| Name | Wallace Oocyte Retrieval Set |
| Classification | Assisted Reproduction Needles, 21 CFR 884.6100 |
| Predicate | 884.6100 Assisted reproduction needles
21 CFR Part 884
[Docket No. 97N - 0335]
Obstetrics and Gynecologic Devices; Reclassification of Medical Devices Used for In
Vitro Fertilization and Related Assisted Reproduction Procedures.
Effective Date: October 13, 1998 |
| Description | Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-
guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set
consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex)
tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is
33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the
distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of
guidance by hand. Tubing is attached to the hub of the needle and protrudes a total
distance of 700mm until it passes through a silicone bung and terminates in an ABS
female luer connector. FEP tubing for suction also protrudes through the bung, and at the
other end terminates in a polypropylene luer lock connector. |
| Intended Use | The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery
and collection of oocytes from ovarian follicles. |
| Contraindications | Not intended for use in the presence of or after recent pelvic inflammatory disease or
chronic cervical infection.
Not intended for placement of fertilized oocyte(s) into the fallopian tube. |
| Caution | Federal law (U.S.A.) restricts this device to sale by or on the order of a physician |
| Technological
Characteristics | There are no published standards for these particular types of products, and as such tests
have been developed which are considered sufficient to ensure the efficacy and safety of
the device(s) for its intended use. Such tests include - Visual; Dimensional; Functional;
two-cell Mouse Embryo Assay; and Bacterial Endotoxin (Limulus Amoebocyte Pyrogen)
Test. |
| Data Submitted | The biological safety assessment of the Wallace Oocyte Retrieval Set has been performed
in accordance with the International Standard ISO 10993, Part 1:1994, "Biological
Evaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993 the
selection of tests, taking into consideration the particular application of the product e.g.
collection of human oocytes, embryo toxicity and bacterial endotoxin tests were
performed. |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2001
Miss Clair Mullins Registration Manager SIMS Portex Limited Hythe KENT CT21 6JL UNITED KINGDOM Re: K012068
Wallace Oocyte Retrieval Sets Dated: June 14, 2001 Received: July 2, 2001 Regulatory Class: II 21 CFR §884.6100/Procode: 85 MQE
Dear Miss Mullins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decembed the We have reviewed your Section > Inchications of mich to the stated in the online of the markets of endicate devices of to device device is substantially equivalent (tor the macknows to tuse sacontant and Chica Amendments, or to devices, or to devices, or to devices, or to devices of to devices of to de marketed in interstate commerce provisions of the Federal Food, Doug, and Comments Act (Act). You may,
that have been reclassified in accordance with the provisions of the e that have been reclassified in accordance with the provisions of the provisions of the general controls provisions of the Act therefore, market the device, subject on the general collives, proctice, and rear of the grouped and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) it may be subject in the Code of Federal Regulations If your device is classitied (see above) into ellier class it (openal outders) or the Code of Fegel in the Code of Fegel Megulations to such additional controls. Existing major regulations arecunes contributes with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantially equivalent dece Title 21, Parts 800 to 895. A substantany equivalion (QS) for establical Devices: Central regulation (21 CFR Part Practice requirements, as set forth in the Quality System Negation (FDA) will benify such assumptions. Failure
820) and that, through periodic QS inspections, the Food and Dr 820) and that, through periodic (ite rood and Ding I handidan. FDA may publish further announcements
to comply with the GMP regulation may result in regulatory actions resear to comply with the GMP regulation may result in tregulation in are more notification submission doss not
concerning your device in the Federal Register. Please notes to your concerning your device in the Federal Register. Trease note for essent of your possess under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarke notification for your device and This letter will allow you to begin marketing your device as described 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 Pat 80 and additionally 80.10 to rin vitro If you desire specific advice tor your device of Gon increat (301) 594-4639. Additionally, for questions on the promotion diagnosic devices), please contact the Office of Complance at (301) 594-4639. Also, please not the regulation of vegation on veur and advertising of your device, premarket notification (1). Other general information on your of entitled, "Misbranding by reterence to prematic notition of Small Manufactures Assistance at its toll-free number (800)
responsibilities under the Act may be obtained from th responsibilities under the Acc may of obtained from the Driller of St...
638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmamain.html".
Sincerely vours
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 (s)
Image /page/1/Picture/17 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
2
INTENDED USE STATEMENT
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
CONTRAINDICATIONS:
Not intended for use in the presence of or after recent pelvic inflammatory disease.
Not intended for intrafallopian tube procedures.
CAUTIONS:
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
David A. Segmour
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
6 Prescription Use . (Per 21 CFR 801.109)