STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

K993448 · Ela Medical, Inc. · DTB · Apr 10, 2000 · Cardiovascular

Device Facts

• Record ID: K993448
• Device Name: STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
• Applicant: Ela Medical, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Apr 10, 2000
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended 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.

Device Story

Stela™ pacing leads are transvenous, silicone rubber leads providing permanent electrical pathways between implantable pacemakers and heart chambers. Straight models (BT45/46, UT46) target the ventricle; J-shaped models (BJ44/45, UJ45) target the atrium. Device modification involves replacing the straight extruded tubing material (inner/outer lead isolation) with Applied Silicone HCRA HP 50E. Leads are implanted by physicians in clinical settings. Output is electrical pacing/sensing; clinical benefit is maintenance of cardiac rhythm. Modification verified via in-vitro functional testing and biocompatibility assessment.

Clinical Evidence

No clinical data. Evidence consists of in-vitro functional testing (leak resistance, tensile strength, electrical continuity, leakage current, fatigue resistance, abrasion resistance) and biocompatibility testing (ISO 10993-6 tissue analysis after 3-month endocardial implantation in 4 sheep; ISO 10993-4 blood-compatibility including hemolysis and coagulation time).

Technological Characteristics

Transvenous endocardial pacing leads. Materials: Silicone rubber (Applied Silicone HCRA HP 50E). Configuration: Straight (ventricular) or J-shaped (atrial); unipolar or bipolar. Energy: Electrical pacing/sensing. Sterilization: Not specified. Connectivity: Standalone implantable lead.

Indications for Use

Indicated for cardiac pacing and sensing in patients requiring permanent electrical connection between an implantable pacemaker and the heart (ventricle for straight leads, atrium for J-shaped leads).

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external 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. Permanent pacemaker electrode: 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.

Predicate Devices

• ELA Medical Stela™ Model BT45/46 and UT46 (K904255)
• ELA Medical Stela™ Model BJ44/BJ45 (K963698)
• ELA Medical Stela™ Model UJ45 (K972574)

Submission Summary (Full Text)

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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. [phone]

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 tubing<br>components (inner and outer<br>lead isolation) | Dow Corning HP 77020 SP50 | Applied Silicone* HCRA HP<br>50E (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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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "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 [phone] or [phone] 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 |
|---------------------------------------|---|
|---------------------------------------|---|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|