(32 days)
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.
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.
The Wallace Oocyte Retrieval Set is a medical device and therefore its acceptance criteria is based on safety and efficacy rather than performance metrics like sensitivity or specificity.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Performance |
|---|---|
| Visual Inspection | Sufficient to ensure efficacy and safety |
| Dimensional Accuracy | Sufficient to ensure efficacy and safety |
| Functional Performance | Sufficient to ensure efficacy and safety |
| Two-cell Mouse Embryo Assay | Performed and deemed sufficient to ensure efficacy and safety |
| Bacterial Endotoxin (Limulus Amoebocyte Pyrogen) Test | Performed and deemed sufficient to ensure efficacy and safety |
| Biological Safety (ISO 10993, Part 1:1994) | Assessment performed and deemed sufficient to ensure efficacy and safety |
2. Sample Size and Data Provenance
The document does not specify a distinct test set or sample size for each performance test. The device is a "set" implying multiple components and likely multiple units were subjected to these tests. Given the 2001 date, it is highly probable that all testing was retrospective and conducted in the UK, where the applicant (SIMS Portex Ltd) is located.
3. Number of Experts and Qualifications
No information is provided regarding the number or qualifications of experts involved in establishing acceptance criteria or interpreting test results. The implication is that internal company experts conducted and assessed the tests.
4. Adjudication Method
No formal adjudication method is described. The acceptance appears to be based on the internal assessment of the conducted tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The Wallace Oocyte Retrieval Set is a medical device, not an AI or imaging diagnostic tool that would typically involve a multi-reader, multi-case study.
6. Standalone (Algorithm Only) Performance
Not applicable. The Wallace Oocyte Retrieval Set is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth for acceptance appears to be established by adherence to internal company-developed tests and the ISO 10993 standard for biological safety, rather than external expert consensus, pathology, or outcomes data in the context of diagnostic accuracy. The "two-cell Mouse Embryo Assay" provides a biological ground truth for embryo toxicity.
8. Sample Size for Training Set
Not applicable. The device is not an AI model, so there is no "training set."
9. How Ground Truth for Training Set Was Established
Not applicable.
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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 MullinsSIMS Registration ManagerSIMS Portex LtdHytheKent CT21 6JLUK |
|---|---|
| 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 needles21 CFR Part 884[Docket No. 97N - 0335]Obstetrics and Gynecologic Devices; Reclassification of Medical Devices Used for InVitro 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 setconsists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex)tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is33cm in length and available in 16 gauge or 17 gauge, each having echomarking at thedistal tip for ultrasound reflection and a plastic hub at the proximal end for ease ofguidance by hand. Tubing is attached to the hub of the needle and protrudes a totaldistance of 700mm until it passes through a silicone bung and terminates in an ABSfemale luer connector. FEP tubing for suction also protrudes through the bung, and at theother end terminates in a polypropylene luer lock connector. |
| Intended Use | The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recoveryand collection of oocytes from ovarian follicles. |
| Contraindications | Not intended for use in the presence of or after recent pelvic inflammatory disease orchronic 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 |
| TechnologicalCharacteristics | There are no published standards for these particular types of products, and as such testshave been developed which are considered sufficient to ensure the efficacy and safety ofthe 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 performedin accordance with the International Standard ISO 10993, Part 1:1994, "BiologicalEvaluation of Medical Devices: Evaluation and Testing." In addition to ISO 10993 theselection of tests, taking into consideration the particular application of the product e.g.collection of human oocytes, embryo toxicity and bacterial endotoxin tests wereperformed. |
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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.
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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)
§ 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).