(218 days)
In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.
The PICSI™ Sperm Selection Device is a sterile, plastic culture dish with three microdots of hyaluronan hydrogel attached to the dish and three locating lines emoussed on the bottom exterior of the dish to aid the operator to find the microdots. Mature sperm attach themselves to hyaluronan through specific receptors on the sperm plasma membrane. At temperatures from 18-28° C, mature sperm attach firmly to the hyaluronan microdot and no longer exhibit progressive movement, although their tails beat and they are capable of motility. Such sperm are removed from the hyaluronan by micropipet for intracytoplasmic sperm injection (ICSI).
Here's an analysis of the provided information regarding the PICSI™ Sperm Selection Device, focusing on the acceptance criteria and the study that proves its performance:
Considering the device is an Assisted Reproduction Media Labware (a physical culture dish with hyaluronan hydrogel), the "acceptance criteria" here refer to the performance specifications of the product itself, primarily its chemical and physical properties, and its functional performance in a lab setting, rather than a diagnostic device's accuracy metrics (like sensitivity/specificity).
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the PICSI dish to predicate devices (Sperm Catch™ and FALCON® IVF Round Dish) across several attributes. Since explicit "acceptance criteria" (numerical thresholds that must be met) are not directly stated, I will infer them from the comparison table as the performance of the predicate devices or general industry standards for such products where available.
| Factor/Attribute | Acceptance Criteria (Inferred from Predicate Devices/Standards) | Reported Device Performance (PICSI Dish) |
|---|---|---|
| Method of facilitating sperm selection and capture by micropipette | Slows progressive movement (Sperm Catch) / N/A (FALCON) | Stops progressive movement |
| Active Ingredient | Hyaluronan (solution) (Sperm Catch) / N/A (FALCON) | Hyaluronan (hydrogel attached to Petri dish) |
| Sperm fraction subject to selection | Total motile fraction (Sperm Catch) / N/A (FALCON) | Mature motile fraction |
| Useful Operating Temperature | 30-37° C (Sperm Catch) / 0-37°C (FALCON) | 18-28° C |
| Minimum time for set up and selection of sperm | 10 min (Sperm Catch) / N/A (FALCON) | 15 min |
| Storage conditions | (?) Refrigerated (Sperm Catch) / (?) Dry, room temperature (FALCON) | Dry, room temperature |
| Shelf Life | Unknown (Sperm Catch, FALCON) | 1 year (anticipated to be extended as aging studies are completed) |
| Sterility | Filtration sterilized (Sperm Catch) / Radiation sterilized (FALCON) | Radiation sterilized |
| Endotoxin | <1 EU/mL (Sperm Catch) / <20 EU/device (FALCON) | <1 EU/device |
| Biocompatibility | Compatible (>24h survival in human sperm survival assay) (Sperm Catch) / Compatible (2-cell Mouse Embryo Assay, ≥70% conversion in 72h) (FALCON) | Compatible (1-cell Mouse Embryo Assay, ≥75% conversion in 96h) |
| Fertilization Rates (Clinical Trial) | No statistically significant difference from predicate device (implied standard from Sperm Catch) | No statistically significant differences compared to Sperm Catch. |
| Quality of resulting embryos (Clinical Trial) | No statistically significant difference from predicate device | No statistically significant differences compared to Sperm Catch in average number of cells in 3-day embryos, number of 3-day embryos with 8+ cells, morphological characterization of 3-, 5-, 6-day embryos. |
| Disposition of embryos (Clinical Trial) | No statistically significant difference from predicate device | No statistically significant differences compared to Sperm Catch for 3- and 6-day embryos. |
2. Sample size used for the test set and the data provenance
- Sample Size for the test set: Not explicitly stated. The document mentions "a clinical trial involving side-by-side fertilization of oocytes by ICSI, using sperm selected on PICSI and in Sperm Catch." This suggests a comparative study, but the number of patients, oocytes, or sperm samples is not provided.
- Data Provenance: Not specified in terms of country of origin. The study is described as a "clinical trial," implying prospective data collection, though the timeframe or specific study design details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device for use in an assisted reproduction laboratory, not a diagnostic imaging or AI device requiring expert interpretation for ground truth. The "ground truth" here is the biological outcome (fertilization rates, embryo quality, embryo disposition) observed in a clinical setting. The assessment of these outcomes would typically be done by trained embryologists and clinicians, but no specific number or qualifications are mentioned as "experts" for ground truth establishment.
4. Adjudication method for the test set
Not applicable. As a clinical trial assessing biological outcomes, there wouldn't typically be an adjudication method in the sense of resolving conflicting expert opinions on a diagnosis. The outcomes (e.g., fertilization rates, embryo morphology) are usually objectively measured and reported.
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
Not applicable. This device is not an AI algorithm or an imaging device to be interpreted by human readers. It's a labware product used in an assisted reproduction procedure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Its function is to facilitate sperm selection by laboratory personnel during ICSI.
7. The type of ground truth used
The ground truth used was clinical outcomes data related to fertilization and early embryo development. Specifically:
- Fertilization rates
- Average number of cells in 3-day embryos
- Number of 3-day embryos with 8 or more cells
- Morphological characterization of 3-, 5-, and 6-day embryos
- Disposition (outcomes) of 3- and 6-day embryos
8. The sample size for the training set
Not applicable. This device is a physical labware product, not an AI or machine learning model 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.
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APR 1 3 2006
510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K052457.
| Trade/proprietary name: | PICSI™ Sperm Selection Device |
|---|---|
| Common or usual name: | Assisted Reproduction Media,Assisted Reproduction Labware |
Classification: Assisted Reproduction Media, CFR 884.6180, Class II, Procode 85 MQL; Assisted Reproduction Labware, CFR 884.6160, Class II, Procode 85 MQK
PICSI is substantially equivalent to Sperm Catch™ Assisted Reproduction Media, (510(k) K011607, decision date: 8/10/2001) and to FALCON® IVF Round Dish, (510(k) K991253, decision date 5/5/1999)
The PICSI™ Sperm Selection Device is a sterile, plastic culture dish with Description: three microdots of hyaluronan hydrogel attached to the dish and three locating lines three microuots of the bottom exterior of the dish to aid the operator to find the microdots. emoussed on the boundtiach themselves to hyaluronan through specific receptors on the Mature hema membrane. At temperatures from 18-28° C, mature sperm attach sperin prasmamy to the hyaluronan microdot and no longer exhibit progressive movement, although their tails beat and they are capable of motility. Such sperm are movement, atthough moved from the hyaluronan by micropipet for intracytoplasmic sperm injection (ICSI).
Intended Use: PICSI is intended for the selection of mature sperm for ICSI.
| Factor/attribute | PICSI dish | Sperm Catch | FALCON dish |
|---|---|---|---|
| Method of facilitatingsperm selection andcapture bymicropipette | Stops progressivemovement | Slowsprogressivemovement | N/A |
| Active Ingredient | Hyaluronan(hydrogelattached to Petridish) | Hyaluronan(solution) | N/A |
| Sperm fraction subject | Mature motile | Total motile | N/A |
Technological Characteristics Compared to Sperm Catch and to FALCON IVF dish:
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| to selection | fraction | fraction | fraction |
|---|---|---|---|
| Useful OperatingTemperature | 18-28° C | 30-37° C | 0-37°C |
| Minimum time for setup and selection ofsperm | 15 min | 10 min | N/A |
| Storage conditions | Dry, roomtemperature | (?) Refrigerated | (?) Dry, roomtemperature |
| Shelf Life | 1 y (anticipated tobe extended asaging studies arecompleted) | Unknown | Unknown |
| Sterility | Radiationsterilized | Filtrationsterilized | Radiationsterilized |
| Endotoxin | <1 EU/device | <1 EU/mL | < 20 EU/device |
| Biocompatibility | Compatible (1-cell MouseEmbryo Assay,≥75% conversionin 96 h) | Compatible(> 24 h survivalin human spermsurvival assay) | Compatible (2-cellMouse EmbryoAssay, ≥ 70%conversionin 72 h) |
Performance: In a clinical trial involving side-by-side fertilization of oocytes by ICSI, using sperm selected on PICSI and in Sperm Catch, the fertilization rates, quality of the resulting embryos and the disposition of embryos in the PICSI and the Sperm Catch groups were compared. No statistically significant differences were found in fertilization rates, the average number of cells in the 3-day embryos, the number of 3-day embryos with 8 or more cells, the morphological characterization of the 3-, 5- and 6-day embryos and the disposition (outcomes) of the 3- and 6-day embryos.
Signature
James B. Johnston
22 February 2006
Date
K 052457 Premarket Notification [510(k)] Number
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 8 2006
James B. Johnston, Ph.D. Principal Investigator BIOCOAT Incorporated 211 Witmer Road HORSHAM PA 19044
Re: K052457
Trade/Device Name: PICSI™ Sperm Selection Device Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Product Code: MQK Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Product Code: MQL Regulatory Class: II Dated: February 24, 2006 Received: February 27, 2006
Dear Dr. Johnston:
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 (Premarket Approval), 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.
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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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Indications for Use
510(k) Number (if known): K052457
Device Name: PICSI Sperm Selection Device
Indications For Use: In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymann
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 510(k) Number.
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§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.