(265 days)
The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease.
The device is indicated for:
- The palliation of dyspnea due to pleural effusion
- Providing pleurodesis (resolution of the pleural effusion)
This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.
Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, it contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and no drugs. It is for use by surgeons where the patients are already draped and insertion components are readily available. The Rocket IPC Insertion Kits are provided sterile and are for single use only.
The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone catheter, with a barium sulfate stripe through its length, intended for the drainage of pleural effusion. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the pleural space. This valve can only be operated with the specifically designed drainage line and drainage bottles supplied by Rocket Medical.
The provided text is a 510(k) Summary for a medical device (Rocket Indwelling Pleural Catheter (IPC) Insertion Kit). It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a new clinical study to prove the device meets specific acceptance criteria in the manner one would for a novel AI/software medical device.
Therefore, many of the typical bullet points for AI/software device evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, ground truth establishment for AI models) are not applicable to this document, as it outlines a comparison to a predicate device based on existing performance data and technical specifications.
However, I can extract the closest information analogous to "acceptance criteria" and "device performance" in the context of this 510(k) submission, which revolves around demonstrating that the new device is as safe and effective as the predicate.
Here's an interpretation based on the provided text:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):
The "acceptance criteria" here are implicitly that the subject device's performance characteristics match or are demonstrably equivalent to those of the predicate device. The "reported device performance" is not from new testing of the subject device (for most aspects), but rather a statement that its performance is identical to the predicate due to identical components and principles.
| Acceptance Criteria (Implicitly, as per Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Performance per EN 1617:1997 & EN 1618:1997: Resistance to deformation; force at break-connections; force at break-drainage catheters and all other parts; freedom from leakage. | "Since the main components of the devices are identical, the performance testing performed on the predicate is applicable to the subject device. All testing met acceptance criteria." (Implying the subject device also meets these, as it's identical). |
| Biocompatibility per ISO 10993-1: Cytotoxicity, sensitization, irritation, system toxicity, subchronic toxicity, genotoxicity, implantation, exhaustive extraction, summary report and biological risk assessment. | "Since the main components of the devices are identical, the biocompatibility testing performed on the predicate is applicable to the subject device. All testing met acceptance criteria." (Implying the subject device also meets these, as it's identical). |
| Sterility: SAL 10⁻⁶ | "Same as subject device." (Meaning the predicate achieved this). "The subject device and predicate are sterilized using the same method, the same sterility level and the same residual testing." (Implying the subject device also meets this). |
| Sterilization Method per ISO 11135-1 and ISO 10993-7: EtO and EtO residuals. | "Same as subject device." (Meaning the predicate used this). "The subject device and predicate are sterilized using the same method, the same sterility level and the same residual testing." (Implying the subject device also meets this). |
| Shelf life: (Predicate had 3 years) | "The shelf life will not exceed the shelf life of any of its kit components when packaged." "Since the subject device is identical to the predicate except for the Lidocaine HCl, USP and DuraPrep, the stability testing on the predicate is applicable to the subject device. The shelf life of the Lidocaine HCl, USP and DuraPrep are determined and monitored by the manufacturers." (Demonstrates compatibility with components' existing shelf lives). |
| Packaging components and materials: APET tray, blue field wrap, uncoated Tyvek 1073B/PET pouch, folding carton. | "Same as subject device." (Meaning the predicate used these). "The subject device and predicate use the same packaging materials and process." (Implying equivalence). |
| Indications for Use: (Slight difference in convenience kit components, but not fundamental indication) | "Same as subject device except... no impact on substantial equivalence." |
| Technological Features (Catheter and Drainage Line): Tubing, cuff, one-way valve, cap, locking section. | "Since the subject device and the predicate device catheters and drainage line are identical, they have identical technological features." |
| Principle of Operation (Catheter and Drainage Line): Attached via one-way valve to vacuum bottles/wall suction for drainage; one-way valve prevents air/fluid migration. | "Since the subject device and the predicate catheters and drainage line are identical, they have identical principles of operation." |
| Materials (Catheter and Drainage Line): Silicone tubing with barium sulfate stripe, polyester cuff, silicone adhesive, ABS one-way valve and cap; PVC tubing and ABS one-way valve and locking section. | "Since the subject device and the predicate catheters and drainage line are identical, they have identical materials." |
Regarding the study that proves the device meets acceptance criteria (interpreted as proof of substantial equivalence):
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Sample size used for the test set and the data provenance:
- This is not a "test set" in the machine learning sense. The "study" for substantial equivalence relies on existing data and specifications of the predicate device (K123033) and a reference predicate (K162457).
- No new clinical data or specific sample sizes are mentioned for demonstrating the subject device's performance (outside of the pre-existing data for the predicate).
- Provenance: The predicate device (K123033) and reference predicate (K162457) are also from Rocket Medical PLC, GB. The general context of 510(k) submissions relies on historical data and verified performance of existing devices. The terms "retrospective" or "prospective" are not applicable here, as it's a comparison to established devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert ground truth for a test set. The "truth" is established by the prior FDA clearances of the predicate devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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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 is a physical medical device, not an AI/software device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for proving substantial equivalence relies on pre-existing regulatory clearances, performance data, and technical specifications of the predicate device(s). For the added components (Lidocaine HCl, USP and DuraPrep), their "ground truth" for safety and efficacy comes from their individual clearances and conformance to USP monographs and manufacturer validations (e.g., for EtO sterilization).
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The sample size for the training set:
- Not applicable. This refers to AI/ML model training, which is not relevant here.
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How the ground truth for the training set was established:
- Not applicable. This refers to AI/ML model training, which is not relevant here.
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).