(89 days)
The Selectra accessory kit is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
The Selectra accessory kit includes a variety of commonly used catheter accessories which are combined in a single package. The Selectra accessory kit includes the following components: 1 Selectra Slitter Tool, 1 Seldinger Guide Wire, 4 Transvalvular Insertion (TVI) Tools, 1 Syringe, 1 Torquer, 2 Stopcocks, 2 Check valves, 2 Sealing caps, 1 Technical Manual. The Selectra accessory kit may be used with the Selectra CS lead introducer system, BIOTRONIK's family of guiding catheters specifically used for the placement of coronary sinus leads.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with specific acceptance criteria in the way a clinical trial would. Therefore, many of the requested elements pertaining to clinical performance, ground truth, expert opinions, and AI effect sizes are not applicable here.
Here's a breakdown of what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily based on ensuring the modified device maintains the same characteristics and performance as the predicate device. The document explicitly states:
- Acceptance Criteria: The usage, indications for use, contraindications, and function of the Selectra accessory kit must remain unchanged compared to the predicate device (ScoutPro ACS accessory kit, K101776). The changes are "minor component modifications."
- Reported Device Performance: The document implicitly states that the device meets these criteria by asserting, "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use, contraindications, and function, are the ScoutPro ACS accessory kit cleared on July 23, 2010 (K101776). Therefore, this previously cleared accessory kit will serve as the predicate device for the modified accessory kit included in this Special 510(k)."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Usage remains unchanged. | "The usage of the Selectra accessory kit remains unchanged." |
| Indications for Use remain unchanged. | "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as indications for use... are the ScoutPro ACS accessory kit cleared on July 23, 2010." (The indications listed for the current device are identical to the predicate's implied indications for assisting lead implantation in the left side of the heart via the coronary sinus.) |
| Contraindications remain unchanged. | "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as... contraindications... are the ScoutPro ACS accessory kit cleared on July 23, 2010." |
| Function remains unchanged. | "The usage of the Selectra accessory kit remains unchanged and the product characteristics, such as... function... are the ScoutPro ACS accessory kit cleared on July 23, 2010." |
| Changes are minor component modifications. | "The changes made to the Selectra accessory kit, as compared to the previously cleared ScoutPro ACS accessory kit, primarily include minor component modifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a device modification (Special 510(k)) and is based on maintaining substantial equivalence to a predicate device, not on specific clinical trial data with a test set in the traditional sense. The evidence provided typically involves engineering and bench testing to demonstrate that the minor component modifications do not alter the safety or effectiveness of the device. There's no mention of a clinical "test set" from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As noted above, this is not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or human adjudication process for clinical data is described.
5. 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 device is a component kit for a lead introducer system; it does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical accessory kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this type of submission is the documented performance and characteristics of the legally marketed predicate device. The new device is compared against the predicate's established performance through engineering and design verification.
8. The sample size for the training set
- Not Applicable. There is no training set in the context of device modification for substantial equivalence.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).