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510(k) Data Aggregation
(73 days)
COOPERSURGICAL MALLEABLE SYTLET
The sterile singe-use devices are to be used in conjunction with CooperSurgical Assisted Reproduction Catheters for in-vitro fertilization procedures where passage through the cervix is impeded.
Assisted Reproduction Catheters / Stylets are single-use sterile devices provided for use with CooperSurgical Assisted Reproduction Catheters, should passage through the cervix be impeded. The devices have an overall length of 23cm and 18cm and consist of a malleable inner stylet and a detachable rigid outer sheath, which is attached to the flexible inner stylet by a male/female Luer Lock adaptor. When the outer sheath Luer is attached to the hub of the stylet, the inner malleable stylet forms a smooth radius at the outer sheath. The outer sheath has a series of 1cm graduations at the distal end. The stainless steel stylet is encapsulated in Teflon (FEP).
The CooperSurgical Malleable Stylet, as described in the 510(k) Premarket Notification K023382, is a single-use sterile device intended for use with CooperSurgical Assisted Reproduction Catheters during in-vitro fertilization procedures when passage through the cervix is impeded.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a Class II medical device, the acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device. This typically means showing that the new device has the same intended use, technological characteristics, and performance as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Intended Use | The device must have the same intended use as the predicate device. | "The sterile singe-use devices are to be used in conjunction with an Edwards Catheter for in-vitro fertilization procedures where passage through the cervix is impeded." This matches the intended use of the Wallace Malleable Stylets - K990349. |
| Material Composition | Device materials must be compatible with biological systems and comparable to predicate. | "The subject devices are composed of the same materials..." (compared to predicate). Specific materials are listed: Teflon (FEP) for outer sheath and encapsulation, Stainless Steel (316) for inner rod (no patient contact), Polypropylene for luers, Polyethylene for tip protector (no patient contact). Biocompatibility testing equivalent to ISO 10993-1 requirements was performed. |
| Sterilization Method | The device must be sterilized using the same method as the predicate device. | "sterilized using the same method..." (compared to predicate). The document implies the sterilization method is the same as the predicate, but the specific method is not detailed in the provided text. |
| Working Dimensions | The device's working dimensions must be comparable to the predicate device. | "has the same working dimensions." (compared to predicate). Overall lengths are 23cm and 18cm. Minor differences noted: "the luers of the subject device are slightly larger (both in diameter and length) than the predicate device." The manufacturer asserts these are minor differences. |
| Performance Standards | The device must comply with relevant performance standards. | "complies with the same standards." (compared to predicate). Specifically mentioned: "The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements." This demonstrates acceptable mechanical fit for luer connectors. |
| Packaging | Packaging must ensure sterility and device integrity. | "The subject device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film." This is a minor difference, and the new packaging (flexible pouch of Tyvek heat sealed to polyethylene film) is described as "designed to be peeled open," indicating suitability for maintaining sterility. |
| Safety and Effectiveness | Overall, the device must be as safe and effective as the predicate device. | The conclusion states: "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices." This is the ultimate objective of demonstrating substantial equivalence, supported by matching intended use, materials, sterilization, dimensions, and compliance with standards, and providing data for any differences (e.g., biocompatibility for materials, luer fitment for dimensions). The FDA's substantial equivalence determination (K023382) confirms acceptance of this conclusion. |
2. Sample Size for Test Set and Data Provenance
For this 510(k) submission, the "test set" does not refer to a clinical study involving a patient cohort or a typical algorithm validation set. Instead, the "testing" involves bench testing to confirm material properties and mechanical performance.
- Sample Size: Not explicitly stated as a number of stylets tested, but refers to testing conducted on device materials and luer fittings. It's implied that sufficient samples were tested to demonstrate compliance with the referenced ISO standards.
- Data Provenance: The biocompatibility and luer taper testing would have been conducted in a laboratory setting, likely by the manufacturer or a contract testing organization. This is not clinical data (e.g., from a specific country or retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth for the Test Set
Not applicable. This type of regulatory submission for a simple medical device like a stylet does not involve human experts establishing ground truth for performance in the way an AI diagnostic algorithm would. The "ground truth" here is objective physical and chemical properties confirmed by standardized laboratory tests (e.g., ISO standards for biocompatibility and luer fit).
4. Adjudication Method for the Test Set
Not applicable. As described above, no expert adjudication process is relevant for bench testing of material properties and mechanical dimensions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is typically conducted for diagnostic imaging devices or AI algorithms where human interpretation is involved. This device is a surgical accessory, and its effectiveness is assessed through its physical and mechanical properties for its intended use, not through human reading of images or data.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
No. This device is not an algorithm or software. It is a physical medical instrument. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth used for demonstrating the device's compliance is based on:
- Objective Technical Standards: Compliance with ISO 10993-1 (Biocompatibility) and ISO 594-1 1986 (Conical fittings with a 6% luer taper).
- Material Specifications: Verifying that the device's components are made from the specified and appropriate medical-grade materials.
- Dimensional Measurements: Confirming the physical dimensions (length, luer size) meet design specifications and are comparable to the predicate.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm 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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