PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

K013120 · Medamicus, Inc. · GZB · Jan 24, 2002 · Neurology

Device Facts

• Record ID: K013120
• Device Name: PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
• Applicant: Medamicus, Inc.
• Product Code: GZB · Neurology
• Decision Date: Jan 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2

Intended Use

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads

Device Story

Percutaneous Introducer Set is a single-use manual surgical instrument; used for percutaneous introduction, manipulation, and removal of stimulation leads following needle entry. Components include HDPE sheath with hub, 304 stainless steel tapered dilator, and 304 stainless steel guidewire directional guide with depth markings. Platinum-iridium marker band included on sheath. Used in clinical settings by physicians; facilitates lead placement for spinal cord stimulation. Device provides a pathway for lead insertion; enables precise positioning. Benefits include smooth transition during insertion and controlled lead manipulation.

Clinical Evidence

Bench testing only. Performance data confirms device meets functional requirements and specifications. Biocompatibility testing performed per ISO 10993 for externally communicating, tissue/bone/dentin-contacting devices with limited exposure.

Technological Characteristics

Materials: HDPE (sheath/hubs), 304 stainless steel (dilator/guidewire), platinum-iridium (marker band). Design: Tapered distal end for smooth insertion; depth markings on guidewire. Sterilization: Sterile barrier (Tyvek/Mylar pouches) with SAL >10^-6. Manual operation; no energy source or software.

Indications for Use

Indicated for percutaneous introduction, manipulation, and removal of stimulation leads in patients requiring spinal cord stimulation for severe intractable pain.

Regulatory Classification

Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• MedAmicus Epidural Introducer (K994097)

Reference Devices

• MedAmicus Coaxial Introducer (K990705)
• Medtronic foramen needles (P970004)
• Medtronic stimulation leads (P970004)

Submission Summary (Full Text)

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JAN 2 4 2002

# 510(k) Summary Dated 1/15/02

# General Information

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| Classification: | Class II |
|-----------------|-------------------------------------------------------------------|
| Trade Name: | Percutaneous Introducer Set |
| Submitter: | MedAmicus, Inc.<br>15301 Highway 55 West<br>Minneapolis, MN 55447 |
| Contact: | Karyl Haskell<br>Quality and Regulatory Affairs Mana |

Quality and Regulatory Affairs Manager
763-577-2257

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# 013120

# Device Identification

- Device Proprietary Name A.
Percutaneous Introducer Set

- B. Device Common name
Percutaneous Introducer

- C. Device Classification name and reference
Therapeutic Devices, Neurological Reference 882.5880

Sec. 882.5880 Implanted spinal cord stimulator for pain relief.

- (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
- (b) Classification. Class II (performance standards).
- D. Device proposed regulatory class

Class II

- Device product code E.
GZB

- F. Classification Panel
Neurological

- Device Performance Standards G.
To date no special controls have been established for these devices. Performance standards as required by Section 514 of the Federal Food, Drug and Cosmetic act and implemented by 21CFR Part 861 have not been established for percutaneous introducer sets.

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# Predicate Device

MedAmicus Epidural Introducer (K994097)

#### Device Descriptive Information

#### General Description

The Percutaneous Introducer Set is a single use device allowing for introduction, manipulation, and removal of stimulation leads after percutaneous entry is gained with a needle. The sheath is made of HDPE (High Density Polyethylene) with a HDPE hub. It is slightly tapered at the distal end to make a smooth transition to the dilator. The dilator is made of 304 stainless steel tubing tapered at the distal end for smooth insertion. It has a molded HDPE hub. The guidewire directional guide is made of 304 stainless steel wire with radiuses at each end. It has depth markings etched into the surface along the distal end.

# Intended Use

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads

#### Biocompatability

Per ISO 10993 this device is classified as Externally Communicating -Tissue/Bone/Dentin Communicating - Limited Exposure. Applications referred to below are for Externally Communicating - Blood Path Indirect - Limited Exposure which includes all the testing required above.

Materials used in the Percutaneous Introducer Set are identical to materials previously approved/cleared for market release. The materials of the sheath, sheath hub, and dilator hub are identical to those used in the MedAmicus Coaxial Introducer (K990705) which is a predicate device for the Epidural Introducer. Both the Epidural and Coaxial Introducer use HDPE with the exception that the Epidural Introducer uses a blue dye in the sheath shaft. The 304 stainless steel use in the dilator shaft and directional guide is identical to the cannulas of Medtronic foramen needles (P970004). The platinum iridium used as a marker band in the introducer sheath is identical to the electrodes of Medtronic stimulation leads (P970004). Since the materials are identical to those previously approved/cleared, there are no new issues involving safety and effectiveness.

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# Device Performance/Product Testing

Performance data indicates that the Percutaneous Introducer Set meets the functional requirements and specifications for this device.

# Technology Characteristics

The device is equivalent technologically to the device mentioned under predicate device above.

# Substantial Equivalence

# Substantial Equivalence Discussion

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads. The intended use, basic design, methods of manufacturing, and materials are similar to the predicate device, the MedAmicus Epidural Introducer.

The sheath materials and manufacturing processes for the Percutaneous Introducer Set are equivalent to those used on the predicate MedAmicus device, the MedAmicus Epidural Introducer (K994097). The 304 stainless steel use in the dilator shaft and guidewire has been used in numerous applications and in particular by Medtronic (P970004) in the cannulas of their foramen needles. The platinum iridium has also been used in numerous applications and in particular by Medtronic (P970004) in the electrodes of their leads.

The packaging materials for the Percutaneous Introducer Set are equivalent to the predicate MedAmicus Epidural Introducer. These materials consist of a double sterile barrier using Tyvek/Mylar pouches. Present sterilization cycle assures a Sterility Assurance Level (SAL) of >10-6.

# Substantial Equivalence Conclusion

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads. The basic design, methods of manufacturing, and materials used are substantially equivalent to the predicate device, MedAmicus Epidural Introducer (K994097). The application of this device is substantially equivalent to the aforementioned device already cleared for market release. The clinical indications for use remain unchanged. MedAmicus

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believes the Percutaneous Introducer Set is substantially equivalent to currently marketed medical introducers employing the same technology and is therefore safe and effective.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 4 2002

Ms. Karyl Haskell Quality Assurance & Regulatory Affairs Manager Medamicus, Inc. 15301 Highway 55 West MINNEAPOLIS, MN 55447

Re: K013120 Trade/Device Name: Model 042294 Lead Introducer Set and Model 3550-18 Lead Introducer Kit Regulation Number: 21 CFR §882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: II Product Code: 84 GZB Dated: December 14, 2001 Received: December 17, 2001

Dear Ms. Haskell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. 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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Applicant: _ MedAmicus, Inc. Applican: Internet (if known): New Submission LL13120 510(K) Number (II Known): Trans 3550-18 Percutaneous Introducer Set Indications For Use:

The Percutaneous Introducer Set is indicated for percutaneous introduction, manipulation, and removal of stimulation leads.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Nancy C. Brandon

(Division Sign Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _

Prescription Use . 1 … (Per 21 CFR 801.109)