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)

AI/ML Overview

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.

Summary

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APR 1 0 2000

K993448

Special 510(k): Device Modification, for Stela leads (silicone tubing change) ELA Medical, Inc.

2. Summary & Certification

2.1 Summary of safety and effectiveness information

2.1.1 General Information

Device Generic Name: Endocardial pacing lead.

Device Trade Name: Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 Pacing Leads

Applicant's Name and Address: ELA Medical, Inc., 2950 Xenium Lane North, Plymouth, MN 55441, Tel. (612) 519-9400

Date of Summary Preparation:

Contact Person: Catherine G. Goble

510(k) Number: K

Date of Judgment of Substantial Equivalence Sent to Applicant:

Predicate Devices:

Device	510(k) Number
ELA Medical Stela™ Model BT45/46 and UT46	K904255
ELA Medical Stela™ Model BJ44/BJ45	K963698
ELA Medical Stela™ Model UJ45	K972574

2.1.2 Description of Conditions for Which the Devices are Indicated

The Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads are indicated for cardiac pacing and sensing, which is the same as other transvenous pacing leads.

2.1.3 Device Description

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:

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Special 510(k): Device Modification, for Stela leads (silicone tubing change) ELA Medical, Inc.

Affected components	Current material	New material
Straight extruded tubingcomponents (inner and outerlead isolation)	Dow Corning HP 77020 SP50	Applied Silicone* HCRA HP50E (part number 40094)

Applied Silicone Corporation, 320 West Stanley Avenue, Ventura CA 93001

2.1.4 Alternatives

The alternatives for Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 leads are other commercially available transvenous pacing leads.

2.1.5 Marketing History

Commercial distribution of the modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 leads has not started anywhere yet.

2.1.6 Potential Adverse Effects

The potential adverse effects of Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads are the same as those for other implantable endocardial leads in commercial distribution. Lead-related complications are described in the ELA Medical generic lead manual.

2.1.7 Summary of Studies

The following in-vitro functional testing was performed on the modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads: leak resistance, tensile strength, electrical continuity, leakage current, fatigue resistance, abrasion resistance.

In addition to raw material biocompatibility test results provided in Applied Silicone Corporation's Master file, the following biocompatibility tests were performed on products manufactured by ELA Medical using raw materials from Applied Silicone Corporation:

· Implantation, according to ISO 10993-6: tissue analysis after 3-month endocardial implantation in sheep (4 animals at 3 months).
· Histology, according to ISO 10993-6.
· Blood-compatibility, according to ISO 10993-4: hemolysis test, coagulation time,

2.1.8 Conclusion

The information presented in this submission provides reasonable assurance that the modified Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing leads will perform in a safe and effective manner.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

APR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Catherine G. Goble Regulatory Affairs Manager ELA Medical, Inc. 2950 Xenium Lane North Plymouth, MN 55441

K993448 Re: Stela™ Models UT46, BT45/46, UJ45, and BJ44/45 Endocardial Pacing Leads Regulatory Class: III (three) Product Code: DTB Dated: February 7, 2000 February 10, 2000 Received:

Dear Ms. Goble:

We have reviewed your Section 510(k) notifications of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Catherine G. Goble

This letter will allow you to begin marketing your device as described in your 510(k) premarket notifications. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Chistopher

James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.10 Indications for Use Statement

510 (k) Number: K

Device Name: Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 Pacing Leads.

Indication for Use:

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K993448

Prescription Use (Per 21 CFR 801.109)	X
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Over-The-Counter Use
----------------------	--

Regulation Number and Section

§ 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.