(324 days)
The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.
Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos, consists of the following three items:
• 80 mm PMMA stick (Rapid-iTM)
• 135 mm Mediprene straw equipped with a stainless steel weight, (RapidStraw)
• 115 mm stainless steel rod inserted in the RapidStraw
Here's an analysis of the acceptance criteria and supporting studies for the Rapid-i™ Kit, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance (Rapid-i™ Kit) | Study Proving Performance (Relevant part of the document) |
|---|---|---|---|
| Nonclinical Testing | |||
| Mouse Embryo Assay (MEA) | % expanded blastocyst within 96 hours ≥ 80% | All devices met acceptance specifications (implicitly ≥ 80%). | "Mouse Embryo Assay (re-expanded blastocyst within 96 hours ≥80%) has been performed on three individually tested samples from each of three lots of the proposed device. All devices met acceptance specifications..." (Page 9) |
| Endotoxin Testing (LAL assay) | ≤ 1.0 EU/device | . The statement implies this testing is done routinely. (Page 5) |
* **Sterilization:** No specific sample size given, but validation was performed according to ISO 11737-2:2009. (Page 5)
* **Data Provenance:** Likely internal lab studies by Vitrolife Sweden AB, prospective.
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Design Validation (Comparative Studies, predicate device K090832):
- "Effects of sealing before and after vitrification": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw. No specific sample counts for embryos, but compared "different non-liquid nitrogen (LN2) contact vitrification methods of previously frozen day 1 embryos." (Page 8)
- "A comparative mouse study": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw, using "fresh F1 mouse embryos." (Page 8)
- "A comparative Swiss outbred study": Compared post-seal Rapid-i™ (predicate) and pre-seal Rapid-i™ using "Swiss outbred mice." (Page 8)
- "A vitrification study": No embryos used; visually verified vitrification of media. (Page 8)
- Data Provenance: These were studies related to the predicate device (K090832) for design validation and likely conducted by or for Vitrolife. The nature of the studies suggests prospective experimental designs.
-
Clinical Testing (Blastocyst Vitrification):
- Patients: 426 patients with embryo transfer. (Page 10)
- Data Provenance: Conducted at four sites. It appears to be retrospective collection of results from historical clinical use, stating "The clinical pregnancy rates range between 32% and 47%, and to date, birth of 124 children." and "Clinical blastocyst vitrification was conducted at four sites..." (Page 10)
3. Number of Experts and Qualifications for Ground Truth
- Nonclinical & Shelf-Life Testing (MEA, Endotoxin, Sterilization): No independent experts are explicitly mentioned for establishing ground truth for these tests. These are standard laboratory assays with predefined control samples and acceptance criteria.
- Design Validation (Comparative Studies on Mice/Embryos): No external experts are mentioned. Ground truth was based on defined measurable outcomes like blastocyst development, cell count, and visual assessment of vitrification.
- Clinical Testing: This section references "standard procedures" for embryo assessment and "clinical pregnancy rates" and "birth of 124 children." While embryologists and clinicians are inherently experts, the document does not specify how many or their specific qualifications for establishing ground truth in terms of a consensus panel for this specific submission. The "ground truth" here is objective clinical outcomes (pregnancy, live birth, survival rates) as reported by the clinics.
4. Adjudication Method
- There is no mention of an adjudication method (e.g., 2+1, 3+1) in the document. This type of adjudication is typically for subjective assessments (e.g., image interpretation). Given the nature of these tests (laboratory assays, survival rates, clinical outcomes), such a method would not commonly be applied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. This type of study is more common for diagnostic imaging devices where human readers interpret data, and the comparison is how AI assistance changes their diagnostic accuracy. The Rapid-i™ Kit is a cryopreservation device, not a diagnostic tool requiring human interpretation for its primary function.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The Rapid-i™ Kit is a hardware device for cryopreservation, not an algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
- Nonclinical & Shelf-Life Testing: Objective laboratory measurements (e.g., growth in MEA, endotoxin levels, sterility confirmation).
- Design Validation: Objective experimental outcomes (e.g., blastocyst development rate, cell count, visual assessment of vitrification).
- Clinical Testing: Objective clinical outcomes (embryo survival rate, clinical pregnancy rate, live birth). This is a form of outcomes data.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as the Rapid-i™ Kit is a medical device (hardware) rather than an AI/ML algorithm that requires training data. The studies performed are for validating the product's functional performance and safety.
9. How Ground Truth for the Training Set Was Established
- As the device is not an AI/ML algorithm, there is no "training set" or ground truth for it in that context. The "ground truth" for evaluating the device's performance as a cryopreservation tool is established through the objective measurements and clinical outcomes described above.
§ 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.