(181 days)
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.
ELA Medical Stela™ Model BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle.
ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.
Stela™ Model BT45/46 and UT46 straight tined pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the ventricle.
Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are silicone rubber, transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium.
Stela™ Model UT 46 and UJ45 are silicone rubber, unipolar transvenous leads, similar in design and construction to bipolar models BT45/46 and BJ44/45, respectively.
The following silicone rubber material change was performed on Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads:
Affected components: Straight extruded tubing components (inner and outer lead isolation)
Current material: Dow Corning HP 77020 SP50
New material: Applied Silicone* HCRA HP 50E (part number 40094)
This is not an AI/ML device, therefore, the traditional acceptance criteria and study design elements requested in the prompt (like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are not applicable.
The submission K993448 is a Special 510(k) for a device modification (silicone tubing change) to existing Stela™ pacing leads. The focus is on demonstrating that the modified device remains safe and effective despite the material change, and is substantially equivalent to the previously cleared predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML performance. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device's performance is comparable to or unaffected by the material change, based on established industry standards and internal testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance (In-vitro): | |
| - Maintain leak resistance | Performed in-vitro functional testing. The conclusion states "information presented... provides reasonable assurance that the modified Stela™... will perform in a safe and effective manner," implying these tests were successfully passed and the performance was acceptable. Specific quantitative results are not provided in the summary. |
| - Maintain tensile strength | Same as above. |
| - Maintain electrical continuity | Same as above. |
| - Maintain leakage current within acceptable limits | Same as above. |
| - Maintain fatigue resistance | Same as above. |
| - Maintain abrasion resistance | Same as above. |
| Biocompatibility: | |
| - Meet ISO 10993-6 for implantation (tissue analysis) | Implantation test performed according to ISO 10993-6: tissue analysis after 3-month endocardial implantation in sheep (4 animals). The conclusion implies these tests were successful. |
| - Meet ISO 10993-6 for histology | Histology performed according to ISO 10993-6. The conclusion implies these tests were successful. |
| - Meet ISO 10993-4 for blood-compatibility (hemolysis, coagulation) | Blood-compatibility tests performed according to ISO 10993-4: hemolysis test, coagulation time. The conclusion implies these tests were successful. |
| Substantial Equivalence: | The FDA's 510(k) clearance letter states, "We have determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "acceptance criterion" for a 510(k) submission, confirming that all presented data support this finding. The modified device's indications for use remain the same as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For biocompatibility (implantation): 4 sheep (animals) for a 3-month endocardial implantation.
- For in-vitro functional testing: Not specified in the summary. This would typically involve a certain number of manufactured lead samples (e.g., N=10, N=30) per test, but the exact count isn't provided in the summary document.
- Data Provenance:
- The animal study (sheep) is likely prospective and conducted specifically for this regulatory submission. Country of origin for the animal study is not specified.
- The in-vitro functional tests are laboratory-based and conducted on newly manufactured leads with the new material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not an AI/ML study; therefore, the concept of "experts establishing ground truth for the test set" in that context is not applicable.
- For the animal study histology and tissue analysis, trained veterinary pathologists or researchers would evaluate the results. Their number and specific qualifications are not detailed in the summary.
4. Adjudication method for the test set
- Not applicable as this is not an AI/ML study requiring adjudication of expert interpretations. The evaluation of functional test results and biocompatibility study outcomes would follow standard laboratory and histological assessment protocols, likely by a single qualified individual or a lab team.
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
- No. This is not an AI/ML device; therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device; therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used
- The "ground truth" here pertains to the objective performance characteristics of the physical device and its biological interaction.
- Functional Testing: The "ground truth" is derived from direct measurements and observations during standard in-vitro engineering tests (e.g., measuring tensile strength, electrical resistance, leakage, fatigue cycles).
- Biocompatibility: The "ground truth" is established through histological analysis (microscopic examination of tissue response) and blood tests (hemolysis, coagulation time) following internationally recognized standards (ISO 10993). This is direct biological and pathological evidence.
8. The sample size for the training set
- Not applicable. This is a physical device modification, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.