(89 days)
The Titanium Fletcher-style Applicator Set with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.
The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
Here's a breakdown of the acceptance criteria and study information for the "Titanium Fletcher-Style Applicator Set," based on the provided 510(k) summary:
This device is not an AI/ML device, but a physical medical device. Therefore, the questions related to AI/ML specific studies (MRMC comparative effectiveness study, standalone algorithm performance, training set details) are not applicable. The provided document is a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of performance against acceptance criteria in the way an AI/ML device would.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Titanium Fletcher-Style Applicator Set does not explicitly state "acceptance criteria" in terms of performance metrics (like accuracy, sensitivity, specificity) as one would expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device (K980590 Henschke Type GYN Applicator Set) through a comparison of technological characteristics. The performance is measured by compliance with these characteristics and validation of new features.
| Feature/Specification | Predicate Device (K980590 Henschke Type GYN Applicator Set) | New Device (Titanium Fletcher-Style Applicator Set-Defined Geometry) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Clearance Number | K980590 | N/A | N/A | N/A |
| Compatible Afterloader | VariSource | GammaMed plus, GammaMed 12i(t), VariSource | Compatibility with afterloaders for brachytherapy. | The new device is compatible with GammaMed plus, GammaMed 12i(t), and VariSource afterloaders, demonstrating broader compatibility while retaining compatibility with the VariSource (like the predicate). |
| Intended Use | Radiation brachytherapy in the uterus and cervix. | To treat cancer of the uterus, cervix, endometrium, and vagina. | Same or similar intended use for brachytherapy. | The intended use for the new device is consistent with the predicate, with explicit mention of endometrium and vagina, suggesting a slightly expanded, but still within scope, application for brachytherapy. |
| Indications for Use | HDR radiation treatment of the cervix and uterus. | Brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina. | Same or similar indications for use. | Indications are for brachytherapy in the uterus and cervix (like predicate) and additionally includes endometrium and vagina. This is considered substantially equivalent. |
| Design | Rigid intra-uterine tandem and interlocking colpostats. | Intrauterine Probe with stopper (30°, lengths: 40mm, 60mm, 80mm; optional 30mm, 50mm, 70mm); Colpostats: 20mm, 25mm, 30mm spread. | Functional design for intracavitary radiotherapy. | The new device features an intrauterine probe with specific angles and lengths, and colpostats with defined spreads, indicating a compatible and regulated design for intracavitary application. |
| Materials | Stainless Steel, Polysulphone, Tungsten | PEEK Titanium, stainless steel, PPSU. | Biocompatible materials suitable for medical devices. | Uses PEEK Titanium, stainless steel, and PPSU, which are common and accepted materials for medical devices, expected to be biocompatible and robust. |
| Packing | Individual | Individual | Individual packaging for hygiene and sterility maintenance. | Consistent with predicate. |
| Sterility | Provided Non-sterile | Provided Non-sterile | Device is intended for post-purchase sterilization by user. | Consistent with predicate. |
| Sterilization Method | EtO Gas sterilization or Steam sterilization | Steam sterilization | Validated sterilization method suitable for the device materials. | Validated for Steam sterilization (15min @ 121°C, 5min @ 134°C, 18min @ 134°C), which is a common and effective method. |
| Sterilization Conditions | 30 minutes ±2 minutes at 250°F±5°F (121°C±1°C). | 15minutes @121°C, 5 minutes @134°C, 18 minutes @134°C | Effective sterilization parameters. | Specific steam sterilization parameters are provided, demonstrating validated sterilization efficacy for the device. |
| Biocompatibility | Not mentioned. | Full biocompatibility | Device materials are biocompatible for patient contact. | Explicitly states "Full biocompatibility," indicating testing and compliance with relevant standards. (This is an improvement/clarification over the predicate but supports safety). |
| Anatomical Sites | Uterus, cervix. | Uterus, cervix, endometrium, vagina. | Anatomical sites consistent with intended use. | Expanded to include endometrium and vagina, which aligns with the slightly broadened indications for use and is considered safe and effective in the context of brachytherapy. |
| **Compatibility with environment/ | ||||
| other devices** | Not stated to be CT compatible or MR Conditional for 3 Tesla. | CT compatible, MR Conditional for 3 Tesla. | Functionality in modern imaging environments. | The new device is CT compatible and MR Conditional for 3 Tesla, which are significant improvements over the predicate, enhancing its usability in modern clinical settings. This adds utility without changing the fundamental safety or effectiveness of brachytherapy delivery. |
| Rectal Retractor | Not included as optional accessory. | Included as optional accessory. | Provision of necessary accessories for safe and effective use. | The inclusion of a rectal retractor as an optional accessory enhances a clinician's ability to protect adjacent organs, improving safety and functionality. |
2. Sample Size Used for the Test Set and Data Provenance
For a 510(k) submission of a physical medical device like this, there isn't a "test set" in the sense of a dataset of patient images or clinical outcomes used for an algorithm's performance evaluation.
Instead, "testing" involves:
- Engineering verification and validation (e.g., material testing, sterilization validation, dimensional accuracy, compatibility with afterloaders).
- Biocompatibility testing.
- MR compatibility testing.
The document does not specify numerical "sample sizes" for these tests in terms of patient data. The provenance of such testing data would typically be from in-house lab testing, vendor testing, and potentially external accredited labs. Such testing is based on established engineering and materials standards, not patient data in the context of a "test set" for an AI device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires expert-established ground truth from diagnostic images or clinical data.
4. Adjudication Method for the Test Set
This question is not applicable. There is no "adjudication method" in the context of a physical device's engineering validation or biocompatibility testing. These tests are evaluated against predefined specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not applicable to a physical brachytherapy applicator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" used for its validation would be:
- Engineering Specifications and Standards: Compliance with dimensional tolerances, material strength, compatibility interfaces.
- Biocompatibility Standards: Compliance with ISO 10993 series.
- Sterilization Validation Protocols: Efficacy of sterilization cycle.
- MR Compatibility Standards: Performance under MR conditions.
It's not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical instrument and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. The device is a physical instrument and does not involve a machine learning training set or its associated ground truth establishment.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.