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510(k) Data Aggregation
(456 days)
Milex Wide-Seal Silicone Diaphragms, in conjunction with an approved spermicidal gel or cream are indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.
The Milex Wide-Seal contraceptive diaphragm is a shallow cup with a flexing rim. The diaphragm is composed of silicone. The diaphragm is placed over the cervix and coated with spermicidal cream or gel to prevent pregnancy. The diagrams are offered in the following sizes: 60mm, 65mm, 70mm, 75mm, 80mm, 85mm, 90mm, 95mm. The diaphragms are offered in two styles: Omniflex (Flat or Coil Style that folds in one place only) and Arcing (Folds in any place to form an arc or bow for insertion).
Here's an analysis of the provided text regarding the acceptance criteria and study for the CooperSurgical Milex Wide-Seal Diaphragms:
Based on the provided 510(k) summary, the device is a contraceptive diaphragm. The submission asserts substantial equivalence to a predicate device, the Ortho McNeil Diaphragm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Substantial Equivalence | Comparison to Predicate Device (Ortho McNeil Diaphragm) in terms of intended use, technological characteristics, safety, and effectiveness. | The main difference is the material composition: the subject device uses silicone, while the predicate uses natural rubber. CooperSurgical believes the differences are minor and that the subject device is "as safe and effective as the predicate device." | This is a claim of equivalence rather than a direct measurement against a predefined numerical acceptance threshold for efficacy or safety. |
| Biocompatibility | General biocompatibility standards for medical devices. | "Subject device has been subjected to and passed a variety of biocompatibility tests." | No specific biological criteria or results are provided. |
| Cleaning Validation | Standards for ensuring adequate cleaning of a reusable device (if applicable) or ensuring manufacturing cleanliness. | "Subject device has been subjected to and passed... cleaning validation." | No specific cleaning validation criteria or results are provided. |
| Functional/Mechanical Testing | Relevant functional and mechanical properties for a contraceptive diaphragm (e.g., flexibility, durability, rim integrity, sizing accuracy). | "Subject device has been subjected to and passed... functional / mechanical testing." | No specific functional/mechanical criteria or results are provided. |
| Clinical Efficacy (Indirect) | Prevention of pregnancy "in conjunction with an approved spermicidal gel or cream." | The document implies efficacy by stating the device's intended use is pregnancy prevention and claiming substantial equivalence to a predicate device that has been on the market for a long time. It also mentions "Over 500,000 Milex silicone Diaphragms have been distributed since the device was introduced in 1962," suggesting real-world usage. | No specific clinical trial data or performance metrics (e.g., Pearl Index, typical use effectiveness) are presented in this 510(k) summary. The approval hinges on substantial equivalence to a pre-amendment device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set or clinical study conducted for this submission with a defined sample size for efficacy or safety. The device's approval is based on substantial equivalence to a predicate device (Ortho McNeil Diaphragm) which was pre-amendment (meaning it was on the market prior to May 28, 1976, and did not undergo the same regulatory scrutiny as new devices). The document broadly mentions "Over 500,000 Milex silicone Diaphragms have been distributed since the device was introduced in 1962," but this refers to historical distribution rather than a controlled study's test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. The submission does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication Method
Not Applicable. There is no described study or test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. This type of study is for evaluating observer performance (e.g., radiologists interpreting images) with and without AI assistance. The device in question is a physical contraceptive diaphragm, not an AI software.
6. Standalone (Algorithm Only) Performance Study
Not Applicable. This device is a physical product, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the current 510(k) submission is historical market performance and regulatory status of the predicate device (Ortho McNeil Diaphragm), coupled with the assumption that the new device, due to its similar design and intended use (despite material changes), would perform equivalently. The predicate's long-standing use (since 1962) implicitly served as evidence of its general safety and effectiveness.
8. Sample Size for the Training Set
Not Applicable. As this is a physical medical device and not an AI/algorithmic device, there is no concept of a "training set" in the context of this 510(k) submission.
9. How Ground Truth for the Training Set Was Established
Not Applicable. (See #8)
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided 510(k) summary does not describe a specific clinical study with a defined methodology, sample size, or measured performance endpoints for the Milex Wide-Seal Diaphragm to prove it meets acceptance criteria in the conventional sense.
Instead, the "study" that proves the device meets acceptance criteria is fundamentally a comparison to a legally marketed predicate device (Ortho McNeil Diaphragm) through the 510(k) substantial equivalence pathway.
The core argument for the device meeting the implicit acceptance criteria (safety and effectiveness) is:
- Substantial Equivalence: The subject device has the same intended use, similar technological characteristics, and (according to the manufacturer) is as safe and effective as the predicate device. The primary difference is material composition (silicone vs. natural rubber).
- Performance Data (Non-Clinical):
- Biocompatibility testing.
- Cleaning validation.
- Functional/mechanical testing.
- All these tests were "passed." (No specific results or criteria are provided in this summary).
- Historical Context: The statement that "Over 500,000 Milex silicone Diaphragms have been distributed since the device was introduced in 1962" suggests a history of real-world use for this type of device, which likely supported the safety argument.
In essence, the "proof" is based on non-clinical testing demonstrating the device's physical properties and biocompatibility, combined with the regulatory finding of substantial equivalence to a long-marketed predicate device. There is no mention of a prospective clinical trial, expert review of data, or comparative effectiveness study against specific efficacy metrics within this document.
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